0334 Negative Pressure Wound Therapy

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(https://www.aetna.com/)
Negative Pressure Wound

Therapy
Clinical Policy Bulletins Medical Clinical Policy Bulletins
Number: 0334
Policy
Policy History
*Please see amendment for Pennsylvania Medicaid
at the end of this CPB. Last Review
Aetna considers negative pressure wound therapy (NPWT) pumps medically

05/24/2019
necessary, when either of the following criteria (I or II) is met:
Effective: 08/16/199
I. Ulcers and Wounds in the Home Setting Next Review: 03/27/2020
The member has a chronic Stage III or IV pressure ulcer (see Appendix Review
below), neuropathic ulcer (e.g., diabetic ulcer), venous or arterial
History
insufficiency ulcer, or a chronic ulcer of mixed etiology, present for at least
30 days. A complete wound therapy program described by criterion A and
criterion B, C, or D below, as applicable depending on the type of wound, Definitions
has been tried or considered and ruled out prior to application of NPWT.
Additional
A. For all ulcers or wounds, the following components of a wound therapy Information
program must include a minimum of all of the following general
measures, which should either be addressed, applied, or considered and
ruled out prior to application of NPWT:
 Application of dressings to maintain a moist wound environment, and
http://www.aetna.com/cpb/medical/data/300_399/0334.html 06/26/2019
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 Debridement of necrotic tissue if present, and

 Documentation of evaluation, care, and wound measurements by a
licensed medical professional, and
 Evaluation of and provision for adequate nutritional status.
B. For Stage III or IV pressure ulcers:
 The member has been appropriately turned and positioned, and

 The member has used a group 2 or 3 support surface for pressure ulcers
on the posterior trunk or pelvis
CPB 0430 - Pressure Reducing Support Surfaces
(see (../400_499/0430.html)
(Note: a group 2 or 3 support surface is not required if the ulcer is not on
the trunk or pelvis), and
 The member's moisture and incontinence have been appropriately

managed.
C. For neuropathic (e.g., diabetic) ulcers:
 The member has been on a comprehensive diabetic management

program, and
 Reduction in pressure on a foot ulcer has been accomplished with
appropriate modalities.
D. For venous insufficiency ulcers:
 Compression bandages and/or garments have been consistently applied,

and
 Leg elevation and ambulation have been encouraged.
II. Ulcers and Wounds Encountered in an Inpatient Setting
A. An ulcer or wound (described in section I above) is encountered in the

inpatient setting and, after wound treatments described in I-A through I-D for
the various types of ulcers above have been tried or considered and ruled
out, it is necessary to initiate NPWT.
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B. The member has complications of a surgically created wound (e.g.,

dehiscence) or a traumatic wound (e.g., pre-operative flap or
graft) where there is documentation of the medical necessity for
accelerated formation of granulation tissue which can not be achieved
by other available topical wound treatments (e.g., other conditions of the
member that will not allow for healing times achievable with other
topical wound treatments).
C. Management of fasciotomy wounds in persons with compartment

syndrome.
In either situation, II-A or II-B, NPWT will be considered medically necessary when
treatment continuation is ordered beyond discharge to the home setting.
Note: NPWT pumps must be capable of accommodating more than 1

wound dressing set for multiple wounds on a member. Therefore, more
than 1 NPWT pump billed per member for the same time period is
considered not medically necessary. See specifications of equipment and
supplies in the Appendix.
III. Contraindication
An NPWT pump and supplies is considered not medically necessary if one or more of
the following contraindications are present:
A. The presence in the wound of necrotic tissue with eschar, if debridement

is not attempted; or
B. Osteomyelitis within the vicinity of the wound that is not concurrently
being treated with intent to cure; or
C. Cancer present in the wound; or
D. The presence of an open fistula to an organ or body cavity within the
vicinity of the wound.
IV. Continued Medical Necessity
For wounds and ulcers described in sections I and II above, once placed on an NPWT
pump and supplies, in order to document continued medical necessity, a licensed
medical professional must do the following:
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A. On a regular basis, directly assess the wound(s) being treated with the
NPWT pump, and supervise or directly perform the NPWT dressing
changes, and
B. On at least a monthly basis, document changes in the ulcer's dimensions

and characteristics.
V. Discontinuation Criteria
For wounds and ulcers described in sections I and II above, an NPWT pump
and supplies will be considered as not medically necessary with any of the
following, whichever occurs earliest:
A. Any measurable degree of wound healing has failed to occur over the prior
month. Wound healing is defined as improvement occurring in either surface
area (length times width) or depth of the wound. There must be
documentation of quantitative measurements of wound characteristics
including wound length and width (surface area), or depth, serially observed
and documented, over a specified time interval. The recorded wound
measurements must be consistently and regularly updated and must have
demonstrated progressive wound healing from month to month; or
B. Four months (including the time NPWT was applied in an inpatient setting
prior to discharge to the home) have elapsed using an NPWT pump in the
treatment of any wound. The medical necessity of NPWT beyond 4 months
will be given individual consideration based upon required additional
documentation; or
C. In the judgment of the treating physician, adequate wound healing has
occurred to the degree that NPWT may be discontinued, or
D. Once equipment or supplies are no longer being used for the member,
whether or not by the physician's order; or
E. When criteria under section on Continued Medical Necessity above,

cease to be met.
VI. Supplies
A. Up to a maximum of 15 dressing kits per wound per month is considered

medically necessary unless there is documentation that the wound size
requires more than 1 dressing kit for each dressing change.
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B. Up to a maximum of 10 canister sets per month is considered medically

necessary unless there is documentation showing a large volume of
drainage (greater than 90 ml of exudate per day). For high volume
exudative wounds, a stationary pump with the largest capacity canister must
be used. Excess utilization of canisters related to equipment failure (as
opposed to excessive volume drainage) is not considered medically
necessary.
See specifications of equipment and supplies in the Appendix.
Note: Staging of pressure ulcers used in this policy is as follows:
Table: Stages of pressure ulcers
List of stages Description

Suspected Purple or maroon localized are of discolored intact skin or blood-
Deep Tissue filled blister due to damage of underlying soft tissue from pressure and/or
Injury shear. The area may be preceded by tissue that is painful, firm, mushy,
boggy, warmer or cooler as compared to adjacent tissue.
Stage I Intact skin with non-blanchable redness of a localized area usually over a
bony prominence. Darkly pigmented skin may not have visible blancing; its
color may differ from the surrounding area.
Stage II Partial thickness loss of dermis presenting as a shallow open ulcer with red
or pink wound bed, without slough. May also present as an intact or
open/ruptured serum-filled blister.
Stage III Full thickness tissue loss. Subcutaneous fat may be visible but bone,
tendon or muscle are not exposed. Slough may be present but does not
obscure the depth of tissue loss. May include undermining or tunneling.
Stage IV Full thickness tissue loss with exposed bone, tendon or muscle. Slough or
eschar may be present on some parts of the wound bed. Often include
undermining and tunneling.
Unstageable Full thickness tissue loss in which the base of the ulcer is covered by
slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown, or
black) in the wound bed.
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Aetna considers NPWT experimental and investigational for the following because
its effectiveness for these indications has not been established (not an all-inclusive
list):
 For use following cardiac surgery (e.g., internal thoracic artery grafting) not
meeting criteria above
 For use following knee arthroplasty not meeting criteria above
 For use following surgical excision of pilonidal sinus disease and for
recurrent pilonidal disease
 For use in closed groin incisions in arterial surgery
 For use in kidney transplantation in recipients not meeting criteria above
 For use in open fracture / traumatic wounds
 Prevention of complications in surgical wounds of the abdomen based upon
presence of diabetes or obesity as risk factors
 Prophylactic use after cesarean delivery
 Prophylactic use after ventral hernia repairs
 Treatment of deep sternal wound infection, partial-thickness burns, tibial
fractures
Aetna considers the use of chemotherapeutic agents (e.g. doxycycline and insulin)
in continuous-instillation or intermittent-instillation NPWT experimental and
investigational because its effectiveness has not been established.
Aetna considers the use of non-powered (mechanical) NPWT devices (e.g., the
Smart Negative Pressure [SNaP] Wound Care System) experimental and
investigational because their effectiveness has not been established.
Aetna considers the use of single-use NPWT devices (e.g., PICO Single Use
Negative Pressure Wound Therapy System; Prevena Incision Management
System) experimental and investigational for all indications (e.g., keloid scarring,
wound care including management of closed sternal incision following thoracic
artery grafting, management of wound sites following mammoplasty, and
prophylaxis after lower extremity fracture surgery) because of insufficient evidence
of their effectiveness. Note: Single-use NPWT devices are not covered under plans
that exclude coverage of supplies; please check benefit plan descriptions.
See also CPB 0244 - Wound Care) (../200_299/0244.html).
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Background
This policy is based in part upon Medicare DME MAC medical necessity criteria for
negative pressure wound therapy (NPWT) pumps.
Negative pressure wound therapy is the controlled application of subatmospheric

pressure to a wound using an electrical pump to intermittently or continuously
convey subatmospheric pressure through connecting tubing to a specialized wound
dressing which includes a resilient, open-cell foam surface dressing, sealed with an
occlusive dressing that is meant to contain the subatmospheric pressure at the
wound site and thereby promote wound healing. Drainage from the wound is
collected in a canister.
Negative pressure wound therapy has been used to promote healing of chronic
wounds and pressure ulcers (decubitus ulcers) by creating controlled negative
pressure over the wound that is thought to increase local vascularity and
oxygenation of the wound bed, reduce edema by evacuating wound fluid, and
remove exudate and bacteria.
More than a dozen systematic evidence reviews produced by independent

organizations have questioned the quality of the evidence supporting the use of
NPWT, including systematic evidence reviews published by the Cochrane
Collaboration (Evans and Land, 2001; Wasiak and Cleland, 2007; Ubbink et al,
2008), Washington State Department of Labor and Industries (2003), Canadian
Coordinating Office for Health Technology Assessment (Fisher and Brady, 2003),
Australian Safety and Efficacy Register of New Interventional Procedures --
Surgical (Pham et al, 2003), NHS Quality Improvement Scotland (NHS QIS, 2003),
Centre for Clinical Effectiveness (Higgins, 2003), Agency for Healthcare Research
and Quality (Samson et al, 2004), Technology Assessment Unit of McGill University
Health Centre (Costa et al, 2005), Institute for Quality and Efficiency in Health Care
(IQWiG, 2006), Ontario Ministry of Health and Long-Term Care (MAS, 2004; MAS,
2006), Galician Agency for Health Technology Assessment (AVALIA-T, 2005), and
BMJ Clinical Evidence (Nelson and Jones, 2006; Nelson and Penthrick, 2007).
Control of intra-abdominal fluid secretion, facilitation of abdominal exploration, and

preservation of the fascia for abdominal wall closure is a major challenge in the
management of patients with an open abdomen. Vacuum-assisted therapy has
been reported to help meet the challenges of managing the open abdomen and
may be useful in patients with abdominal compartment syndromes, traumatic
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injuries, and severe intra-abdominal sepsis. In a review on the management of

patients with open abdomen, Kaplan (2004) concluded that controlled clinical
studies are needed to establish the safety and effectiveness of this treatment
approach and to facilitate the development of treatment guidelines to help manage
an increasingly common group of patients who might benefit from this treatment
approach. A systematic evidence review by the National Institute for Health and
Clinical Excellence (NICE, 2009) found inadequate evidence for the use of NPWT
in open abdominal wounds. The NICE assessment concluded that "[c]urrent
evidence on the safety and efficacy of negative pressure wound therapy (NPWT)
for the open abdomen is inadequate in quality and quantity. There has been
concern about the occurrence of intestinal fistulae associated with this procedure
but there is currently no evidence about whether NPWT is the cause."
Schimmer and colleagues (2007) stated that there are many primary modalities for
managing deep sternal wound infection (DSWI) following cardiac surgery, namely
surgical debridement with primary re-closure in conjunction with irrigation, vacuum-
assisted closure (VAC), and primary or delayed flap closure. These researchers
examined if there is consensus on the primary management of DSWI using one
method as a single line therapy or a combination of these procedures. Therefore, a
questionnaire with regards to the primary treatment modalities of DSWI was
distributed to all 79 German heart surgery centers. All replied to the questionnaire
-- VAC is used in 28/79 (35 %) heart centers as the 'first-line' treatment, 22/79 (28
%) perform primary reclosure in conjunction with a double-tube irrigation/suction
system, and in 29/79 (37 %) clinics both treatment options were used according to
intra-operative conditions. Mostly, as a primary management of DSWI two
treatment modalities are mainly in use: primary reclosure coupled with a double-
tube suction/irrigation system and VAC. The current understanding is based purely
on retrospective studies, not evidence-based medicine. Since prospective
randomized controlled trials (RCTs) have not yet been performed, controlled clinical
trials comparing these treatment modalities are pivotal to define evidence for
patients presenting with DSWI.
Morris et al (2007) noted that although NPWT appears effective, it remains

unknown if it is more effective than other wound closure techniques. In addition,
although many uncontrolled, non-randomized studies describing the effectiveness
of this therapy have been published, few prospective RCTs have been conducted.
Small sample sizes, variable outcome measures across studies, and significant
methodological problems in the available RCTs further limit the conclusions that
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can be drawn regarding the relative effectiveness of vacuum-assisted wound

closure. Analysis of these data provided weak evidence to suggest that NPWT is
superior to saline gauze dressings in healing chronic wounds. The authors
concluded that RCTs comparing healing, costs of care, patient pain, and quality-of-
life outcomes of this treatment to non-gauze type dressings and other treatment
modalities are needed.
Gregor et al (2008) examined the clinical effectiveness and safety of negative

NPWT compared with conventional wound therapy; RCTs and non-RCTs
comparing NPWT and conventional therapy for acute or chronic wounds were
included in this review. The main outcomes of interest were wound-healing
variables. After screening 255 full-text articles, 17 studies remained. In addition,
19 unpublished trials were found, of which 5 had been prematurely terminated.
Two reviewers independently extracted data and assessed methodological quality
in a standardized manner. Seven RCTs (n = 324) and 10 non-RCTs (n = 278) met
the inclusion criteria. The overall methodological quality of the trials was poor.
Significant differences in favor of NPWT for time to wound closure or incidence of
wound closure were shown in 2 of 5 RCTs and 2 of 4 non-RCTs. A meta-analysis
of changes in wound size that included 4 RCTs and 2 non-RCTs favored NPWT
(standardized mean difference: RCTs, -0.57; non-RCTs, -1.30). The authors
concluded that although there is some indication that NPWT may improve wound
healing, the body of evidence available is insufficient to clearly prove an additional
clinical benefit of NPWT. Furthermore, the large number of prematurely terminated
and unpublished trials is reason for concern.
Vikatmaa et al (2008) conducted a systematic review of the literature on the safety

and effectiveness of NPWT for problematic wounds. A total of 14 RCTs were
included. Trials included patients with: (i) pressure wounds, (ii) post-traumatic
wounds, (iii) diabetic foot ulcers, and (iv) miscellaneous chronic ulcers. Only 2
trials were classified as high quality studies, whereas the remaining were
classified as having poor internal validity. The authors concluded that (i) reliable
evidence on the effectiveness of NPWT is scarce, (ii) tentative evidence
indicates that the effectiveness of NPWT is at least as good as or better than
current local treatment for wounds, and (iii) the need for large high-quality
randomized studies is apparent.
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Blume et al (2008) evaluated the safety and clinical efficacy of NPWT compared
with advanced moist wound therapy (AMWT) (predominately hydrogels and
alginates) to treat foot ulcers in diabetic patients in a multi-center randomized
controlled trial (n = 342). The mean age was 58 years and 79 % of subjects were
male. Complete ulcer closure was defined as skin closure (100 % re-epithelization)
without drainage or dressing requirements. Patients were randomly assigned to
either NPWT or AMWT (predominately hydrogels and alginates) and received
standard off-loading therapy as needed. The trial evaluated treatment until day 112
or ulcer closure by any means. Patients whose wounds achieved ulcer closure
were followed at 3 and 9 months. Each study visit included closure assessment by
wound examination and tracings. A greater proportion of foot ulcers achieved
complete ulcer closure with NPWT (73 of 169, 43.2 %) than with AMWT (48 of 166,
28.9 %) within the 112-day active treatment phase (p = 0.007). The Kaplan-Meier
median estimate for 100 % ulcer closure was 96 days (95 % confidence interval
[CI]: 75.0 to 114.0) for NPWT and not determinable for AMWT (p = 0.001). Patients
who received NPWT experienced significantly (p = 0.035) fewer secondary
amputations. The proportion of home care therapy days to total therapy days for
NPWT was 9,471 of 10,579 (89.5 %) and 12,210 of 12,810 (95.3 %) for AMWT. In
assessing safety, no significant difference between the groups was observed in
treatment-related complications such as infection, cellulitis, and osteomyelitis at 6
months. The authors concluded that NPWT appears to be as safe as and more
efficacious than AMWT for the treatment of diabetic foot ulcers.
A technology assessment report on NPWT (Sullivan et al, 2009) prepared for the
Agency for Healthcare Research and Quality found that systematic reviews of
NPWT reveal the following important points about the current state of the evidence
on this technology: (i) all of the systematic reviews noted the lack of high-quality
clinical evidence supporting the advantages of NPWT compared to other

wound treatments; the lack of high-quality NPWT evidence resulted in many
systematic reviewers relying on low-quality retrospective studies to judge the
efficacy of this technology, (ii) no studies directly comparing different NPWT
components (e.g., foam versus gauze dressings) were identified by any of the
reviewers, and (iii) NPWT must be evaluated according to wound type; wound
healing varies according to the type of wound being treated and NPWT benefits
described for one wound type cannot be assumed to apply to other wound
types.
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The assessment stated that the available evidence cannot be used to determine a
significant therapeutic distinction of a NPWT system. In addition, due to the lack of
studies comparing one NPWT system to another NPWT system the severity of
adverse events for 1 NPWT system compared to another could not be determined.
The report concluded, "Clinical research on NPWT capable of indicating if any one
NPWT system or component provides a significant therapeutic distinction requires
study design and conduct that will minimize the possibilities for bias. Important
study design features that were not typically reported such as concealment of
allocation, reporting of randomization methods, use of power analysis to ensure
adequate study size, blinding wound assessors, and reporting of complete wound
healing data will improve the internal validity and the informativeness of the
studies."
More recently, the Johns Hopkins University Evidence-based Practice Center

prepared a comprehensive technology assessment for the Agency for Healthcare
Research and Quality (AHRQ) on the effectiveness of negative pressure wound
therapy (NPWT) on the treatment of chronic wounds in the home care setting
(Rhee et al, 2014). The goal of the assessment was to systematically review the
efficacy and safety of NPWT for treatment of chronic wounds in the home setting.
The authors included studies examining the use of NPWT in patients with chronic
wounds, including venous leg ulcers, arterial leg ulcers, diabetic foot ulcers,
pressure ulcers, and mixed etiology chronic wounds. They retrieved 5,912 citations,
and found seven studies which met the criteria for inclusion. Six of the studies
compared NPWT devices to other wound care methods. One study compared two
different NPWT devices. Ultimately the assessment's authors were unable to draw
any firm conclusions about the efficacy or safety of NPWT for the treatment of
chronic wounds in the home setting due to insufficient evidence. The authors stated
"Though NPWT has been used across the wound care spectrum, significant
research gaps remain. Standardization of wound care research protocols, such as
providing consistency in comparator groups, robust randomized study designs,
larger trials, and common definitions of outcomes, would be helpful in providing
evidence to inform decisions about the use of NPWT."
Negative pressure wound therapy uses a reticulated sponge and subatmospheric

pressure to facilitate healing of a variety of wounds. The therapy appears to assist
wound healing by decreasing wound bacterial burden and edema while facilitating
granulation tissue formation. The latest development in NPWT allows clinicians to
instill continuously a treatment solution and suspension into the wound. A variety of
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wound chemo-therapeutic agents such as insulin, which acts as a growth factor,

may prove helpful in this aspect. Scimeca and colleagues (2010a) presented a
case report in which insulin was used as a chemo-therapeutic agent in continuous-
instillation NPWT. To the authors' knowledge, this is the first report in the literature
describing this method of delivery. Furthermore, Scimeca et al (2010b) described a
real-time streaming therapy of a variety of wound chemo-therapeutic agents
through NPWT. Doxycycline, which acts as a competitive inhibitor of matrix
metalloproteinases and tumor necrosis factor alpha and further decreases
inflammation through the reduction of nitrous oxide production, may prove helpful
when delivered in this manner. To the authors' knowledge, this is the first report in
the literature describing this method of delivery of doxycycline. The clinical value of
chemo-therapeutic agents in continuous-instillation NPWT nees to be ascertained
in randomized, controlled clinical trials.
A non-powered (mechanical) NPWT device, the Smart Negative Pressure (SNaP)

Wound Care System from Spiracur, is a class II device that received 510(k)
marketing clearance from the Food and Drug Administration in 2010 and is
designed to remove small amounts of exudate from chronic, traumatic, dehisced,
acute, subacute wounds and diabetic and pressure ulcers. The lack of well-
designed comparative studies with large number of individuals using the non-
powered NPWT system is insufficient to draw conclusions about its impact on
health outcomes with the device and in comparison with current care.
Armstrong et al (2012) compared the portable mechanically powered Smart

Negative Pressure (SNaP) Wound Care System (Spiracur, Sunnyvale, CA) with the
electrically powered VAC Therapy System (Kinetic Concepts, Inc. [KCI], San
Antonio, TX) in a multicenter, comparative efficacy, noninferiority-powered,
randomized controlled trial. Investigators enrolled 132 people with noninfected,
nonischemic, nonplantar lower extremity diabetic and venous wounds. Each subject
was randomly assigned (1:1) to treatment with either system in conjunction with
appropriate off-loading and compression therapy. The trial evaluated treatment for
up to 16 weeks or complete wound closure (defined as complete reepithelialization
without drainage). Primary end point analysis of wound size reduction found that
SNaP-treated subjects demonstrated noninferiority to the VAC-treated subjects at
4, 8, 12, and 16 weeks (p = 0.0030, 0.0130, 0.0051, and 0.0044, respectively).
Kaplan-Meier analysis showed no significant difference in complete wound closure
between SNaP- and VAC-treated subjects at all time points. Device related adverse
events and complications such as infection were also similar between treatment
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groups. An AHRQ assessment (Rhee et al, 2014) noted study limitations including
lack of blinding, imbalanced study groups particularly in terms of wound size, and
lack of reporting of intervention details. The ARHQ assessment downgraded study
limitations to “high” for the outcome of pain because of limited reporting of statistical
details. All of the outcomes were direct, but the results were imprecise. The AHRQ
assessment stated that they were unable to assess consistency or reporting bias.
The AHRQ assessment noted that the study was funded by the manufacturer of
one of the devices (SNaP) and two of the investigators reported receiving funding
from manufacturers of both devices being evaluated.
The European Pressure Ulcer Advisory Panel's clinical practice guideline on

pressure ulcer treatment (2009) recommended conventional NPWT therapy, but did
not mention non-powered NPWT.
In a systematic review, Roberts et al (2012) determined the comparative safety and

effectiveness of NPWT versus alternate temporary abdominal closure (TAC)
techniques in critically ill adults with open abdominal wounds. These researchers
reviewed published and unpublished comparative studies. They searched
MEDLINE, PubMed, EMBASE, Scopus, Web of Science, the Cochrane Database,
the Center for Reviews and Dissemination, clinical trials registries, and
bibliographies of included articles. Two authors independently abstracted data on
study design, methodological quality, patient characteristics, and outcomes.
Among 2,715 citations identified, 2 RCTs and 9 cohort studies (3 prospective/6
retrospective) met inclusion criteria. Methodological quality of included prospective
studies was moderate. One RCT observed an improved fascial closure rate
(relative risk [RR], 2.4; 95 % CI: 1.0 to 5.3) and length of hospital stay after addition
of retention sutured sequential fascial closure to the Kinetic Concepts Inc. (KCI)
vacuum-assisted closure (VAC). Another reported a trend toward enhanced fascial
closure using the KCI VAC versus Barker's vacuum pack (RR, 2.6; 95 % CI: 0.95 to
7.1). A prospective cohort study observed improved mortality (RR, 0.48; 95 % CI:
0.25 to 0.92) and fascial closure (RR, 1.5; 95 % CI: 1.1 to 2.0) for patients who
received the ABThera versus Barker's vacuum pack. Another noted a reduced
arterial lactate, intra-abdominal pressure, and hospital stay for those fitted with the
KCI VAC versus Bogotá bag. Most included retrospective studies exhibited low
methodological quality and reported no mortality or fascial closure benefit for
NPWT. The authors concluded that limited prospective comparative data
suggested that NPWT versus alternate TAC techniques may be linked with
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improved outcomes. Moreover, they stated that the clinical heterogeneity and
quality of available studies precluded definitive conclusions regarding the
preferential use of NPWT over alternate TAC techniques.
Guidance from tne National Institute for Health and Clinical Excellence (NICE,
2013) stated that current evidence on the safety and efficacy of NPWT for the open
abdomen is adequate to support the use of this procedure provided that normal
arrangements are in place for consent, audit and clinical governance. The guidance
stated that NPWT for the open abdomen may be used to manage open abdominal
wounds in which the gut and other intraperitoneal organs are exposed.
In a Cochrane review, Dumville and Munson (2012) evaluated the effectiveness of

NPWT for people with partial-thickness burns. For this third update we searched
the Cochrane Wounds Group Specialised Register (searched May 18, 2012); the
Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library
2012, Issue 5); Ovid MEDLINE (2010 to week 2 of May 2012); Ovid MEDLINE (in-
process & other non-indexed citations May 17, 2012); Ovid EMBASE (2010 to week
19 of 2012); and EBSCO CINAHL (2010 to May 16, 2012). All RCTs and controlled
clinical trials (CCTs) that evaluated the safety and effectiveness of NPWT for
partial-thickness burns were selected for analysis. Two review authors used
standardized forms, and extracted the data independently. They assessed each
trial for risk of bias, and resolved differences by discussion. One RCT, that was an
interim report, satisfied the inclusion criteria. These investigators undertook a
narrative synthesis of results, as the absence of data and poor reporting precluded
them from carrying out any formal statistical analysis. The trial was at high-risk of
bias. The authors concluded that there was insufficient evidence available to
permit any conclusions to be drawn regarding the use of NPWT for treatment of
partial-thickness burn wounds.
The PICO single-use negative pressure wound therapy device (Smith & Nephew,
Inc., Andover, MA) is a single-use, canister-free, negative pressure wound therapy
device. It is marketed for use in the following types of wounds: chronic; acute;
traumatic; subacute and dehisced wounds; partial-thickness burns; ulcers (e.g.,
diabetic or pressure); flaps and grafts; and closed surgical incisions. The PICO
system contains a disposable, 1-button pump, coupled with an advanced dressing
that negates the need for a canister. The pump is pocket-sized and the dressing
can be worn up to 7 days.
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Fraccalvieri et al (2013) stated that keloid scarring represents a pathological

healing where primary healing phenomenon is deviated from normal. PICO is a
single-use negative pressure wound therapy system originally introduced to
manage open or just closed wounds. PICO dressing is made of silicone, and
distributes an 80 mmHg negative pressure across wound bed. Combination of
silicon layer and continuous compression could be a valid method to manage keloid
scarring. Since November 2011, 3 patients were enrolled and evaluated before
negative pressure treatment, at end of treatment (1 month) and 2 months later,
through Vancouver scar scale (VSS), visual analog scale (VAS) and a scoring
system for itching. Ultrasound (US) and color-power-Doppler (CPD) examination
was performed to evaluate thickness and vascularization of the scar. One patient
was discharged from study after 1 week. In last 2 patients, VSS, VAS and itching
significantly improved after 1 month therapy and the results were stable after 2
months without any therapy. At end of therapy, the appearance of palisade vessels
disappeared in both cases at CPD exam; US showed a thickness reduction
(average of 43.8 %). The authors proposed a well-tolerated, non-invasive
treatment to manage keloid scarring. They stated that prospective studies are
needed to confirm these preliminary findings.
Bendewald et al (2007) stated that complex pilonidal disease, an uncommon

manifestation of an anorectal condition, is characterized by chronic or recurrent
abscesses with extensive, branching sinus tracts. Definitive treatment requires
wide excision of all involved tissue followed by secondary intention healing or
reconstructive surgery. All treatment options have unique advantages and
disadvantages. Following recent reports that negative pressure wound therapy
after surgery for complex pilonidal disease may be a useful alternative to moist
saline dressing treatments, 5 patients (3 men and 2 women, median age of 21
years [range of 16 to 63 years]) with complex pilonidal disease (symptom duration
range of 6 months to 30 years) were treated on an outpatient basis. Following wide
excision under general anesthesia, a portable negative pressure wound therapy
device was applied. Mean wound defect size after excision was 11 cm x 4 cm x 5
cm, or 205 cm(3) (range of 90 cm(3) to 410 cm(3)). Negative pressure wound
therapy was used for an average of 6 weeks (range of 4 to 9 weeks) and mean time
to complete epithelialization was 12 weeks (range of 9 to 22 weeks), including use
of moist saline dressings post-negative pressure wound therapy. Treatment was
discontinued in 1 patient due to skin irritation. No other complications were
observed. The authors concluded that long-term follow-up is needed to assess the
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risk of recurrent pilonidal disease or wound failure following negative pressure

wound therapy. They stated that additional studies of negative pressure wound
therapy in the management of pilonidal disease are warranted.
Farrell and Murphy (2011) noted that pilonidal disease arises from hair follicles of
the gluteal cleft and may result in a chronic exudative disorder. The management
of pilonidal disease following surgical excision remains controversial, despite an
abundance of research into different treatment options. Negative pressure wound
therapy is an emerging treatment option for complex or recurrent pilonidal disease.
These investigators performed a comprehensive literature search, using the
electronic databases MEDLINE, Cochrane library, CINAHL, PubMed, and Web of
Knowledge. All studies, case reports, and multiple case series evaluating the use
of negative pressure wound therapy for treatment of pilonidal disease were
included. Despite the breadth of the search parameters, these researchers
identified limited studies addressing this issue; all were published between 2003
and 2007. Findings of 5 case reports or multiple case series tentatively suggested
that negative pressure wound therapy may be an emerging treatment option for
pilonidal disease management. However, the authors recommended that more
rigorous research, including randomized controlled trials, be conducted before
implications can be drawn for evidence-based practice.
Ousey et al (2013) stated that the management of post-operative spinal wound

complication remains a challenge, with surgical site infection (SSI) incidence rates
ranging from 0.4 % to 20 % after spinal surgery. Negative pressure wound therapy
has been highlighted as an intervention that may stimulate healing and prevent
SSI. However, the wound healing mechanism by NPWT and its effectiveness in
spinal wounds still remain unclear. These researchers systematically searched,
critically appraised, and summarized RCTs and non-RCTs evaluating the
effectiveness of NPWT in patients with a spinal wound. A systematic review based
on search strategies recommended by the Cochrane Back and Wounds Review
Groups was undertaken using Cochrane Library, MEDLINE, EMBASE, and
CINAHL databases. Any publications between 1950 and 2011 were included. A
total of 10 retrospective studies and 4 case studies of patients with spinal wound
complication were included in this systematic review. No RCTs were found; only 1
study described more than 50 patients. Generally, a pressure of -125 mm Hg was
used in adults. Duration of NPWT in-situ ranged from 3 to 186 days. Wound
healing was assessed every 2 to 3 days and generally completed between 7 days
and 16 months. Negative pressure wound therapy is contraindicated in the
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presence of active cerebrospinal fluid leak, metastatic or neoplastic disease in the

wound or in patients with an allergy to the NPWT dressing and in those with a
bleeding diathesis. The authors concluded that published reports were limited to
small retrospective and case studies, with no reports of NPWT being used as a
prophylactic treatment. They stated that larger prospective RCTs of NPWT are
needed to support the current evidence that it is effective in treating spinal wound
complications. In addition, future studies should investigate its use as a
prophylactic treatment to prevent infection and report data relating to safety and
health economics.
Karlakki et al (2013) stated that the period of post-operative treatment before

surgical wounds are completely closed remains a key window, during which one
can apply new technologies that can minimize complications. One such technology
is the use of NPWT to manage and accelerate healing of the closed incisional
wound (incisional NPWT). These investigators undertook a literature review of this
emerging indication to identify evidence within orthopedic surgery and other
surgical disciplines. Literature that supports the current understanding of the
mechanisms of action was also reviewed in detail. A total of 33 publications were
identified, including 9 clinical study reports from orthopedic surgery; 4 from
cardiothoracic surgery and 12 from studies in abdominal, plastic and vascular
disciplines. Most papers (26 of 33) had been published within the past 3 years.
Thus far, 2 RCTs -- 1 in orthopedic and 1 in cardiothoracic surgery -- showed
evidence of reduced incidence of wound healing complications after between 3 and
5 days of post-operative NPWT of 2- and 4-fold, respectively. Investigations
showed that reduction in hematoma and seroma, accelerated wound healing and
increased clearance of edema are significant mechanisms of action. The authors
concluded that there is a rapidly emerging literature on the effect of NPWT on the
closed incision. Initiated and confirmed first with a RCT in orthopedic trauma
surgery, studies in abdominal, plastic and vascular surgery with high rates of
complications have been reported recently. They stated that the evidence from
single-use NPWT devices is accumulating. There are no large randomized studies
yet in reconstructive joint replacement.
Selvaggi et al (2014) noted that surgical site complications (SSC) negatively affect
costs of care and prolong length of stay. Crohn's disease (CD) is a risk factor for
SSC; CD patients often need surgery, sometimes requiring stoma. These
researchers compared the effects on SSC of a portable device for NPWT (PICO)
with gauze dressings after elective surgery for CD. Secondary aims were
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manageability and safety of PICO and its feasibility as home therapy. Between
2010 and 2012, a total of 50 patients were assigned to treatment with either PICO
(n = 25) or conventional dressings (n = 25). Each patient completed 12-month follow-
up. Parameters of interests for primary aim were SSC, surgical complications, and
re-admission rates. Data on difficulties in managing PICO and device-related
complications were also collected. Patients receiving PICO had less SSC, resulting in
shorter hospital stay. At last follow-up, re-admission rates were lower with PICO. No
differences were observed in surgical complications between groups. No patients
reported difficulties in managing the device. Among patients discharged with PICO,
none needed to come back to the hospital for device malfunctioning or inability to
manage it. PICO reduces SSC and length of stay in selected CD patients compared
with conventional dressings. This was a small study (n = 25 for PICO); its findings
need to be validated by well-designed studies.
In a Cochrane review, Webster et al (2014) evaluated the effects of NPWT on

surgical wounds (primary closure, skin grafting or flap closure) that are expected to
heal by primary intention. These investigators searched the following electronic
databases to identify reports of relevant RCTs: the Cochrane Wounds Group
Specialised Register (searched January 28, 2014); the Cochrane Central Register
of Controlled Trials (CENTRAL; 2013, issue 12); Database of Abstracts of Reviews
of Effects (2013, issue 12); Ovid MEDLINE (2011 to January 2014); Ovid MEDLINE
(In-Process & Other Non-Indexed Citations January 24, 2014); Ovid EMBASE
(2011 to Week 44 of January 2014); and EBSCO CINAHL (2011 to January 2014).
These researchers conducted a separate search to identify economic evaluations.
They included trials if they allocated patients to treatment randomly and compared
NPWT with any other type of wound dressing, or compared one type of NPWT with
a different type of NPWT. They assessed trials for their appropriateness for
inclusion and for their quality. This was done by 3 review authors working
independently, using pre-determined inclusion and quality criteria. In this first
update, these investigators included an additional 4 trials, taking the total number of
trials included to 9 (785 participants) -- 3 trials involved skin grafts, 4 included
orthopedic patients and 2 included general surgery and trauma surgery patients; all
the included trials had unclear or high risk of bias for one or more of the quality
indicators we assessed. A total of 7 trials compared NPWT with a standard
dressing (2 of these were 'home-made' NPWT devices), 1 trial compared one 'home-
made' NPWT with a commercially available device. In trials where the individual was
the unit of randomization, there were no differences in the incidence of surgical site
infections (SSI); wound dehiscence, re-operation (in incisional
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wounds); seroma/hematoma; or failed skin grafts. Lower re-operation rates were

observed among skin graft patients in the 'home-made' NPWT group (7/65; 10.8 %)
compared to the standard dressing group (17/66; 25.8 %) (RR 0.42; 95 % CI: 0.19
to 0.92). The mean cost to supply equipment for VAC® therapy was US$ 96.51/day
compared to US$ 4.22/day for one of the 'home-made' devices (p value 0.01); labor
costs for dressing changes were similar for both treatments. Pain intensity score
was also reported to be lower in the 'home-made' group when compared with the
VAC® group (p value 0.02). One of the trials in orthopedic patients was stopped
early because of a high incidence of fracture blisters in the NPWT group (15/24;
62.5 %) compared with the standard dressing group (3/36; 8.3 %) (RR 7.50; 95 %
CI: 2.43 to 23.14). The authors concluded that the evidence for the effects of
NPWT for reducing SSI and wound dehiscence remains unclear, as does the effect
of NPWT on time to complete healing. Rates of graft loss may be lower when
NPWT is used, but hospital-designed and built products are as effective in this area
as commercial applications. There were clear cost benefits when non-commercial
systems were used to create the negative pressure required for wound therapy,
with no evidence of a negative effect on clinical outcome. In 1 study, pain levels
were also rated lower when a 'home-made' system was compared with a
commercial counterpart. The high incidence of blisters occurring when NPWT is
used following orthopedic surgery suggested that the therapy should be limited until
safety in this population is established. They stated that given the cost and
widespread use of NPWT, there is an urgent need for suitably powered, high-
quality trials to evaluate the effects of the newer NPWT products that are designed
for use on clean, closed surgical incisions. Such trials should focus initially on
wounds that may be difficult to heal, such as sternal wounds or incisions on obese
patients.
Kostaras et al (2014) stated that NPWT has been suggested to have a positive
impact on the healing of sternal or extremity wounds. However, few data deriving
from breast surgery have been published. These researchers evaluated the
available literature regarding the effectiveness of NPWT systems in the healing of
breast tissues. The PubMed and Scopus databases were searched systematically,
and all studies that provided relevant data were considered eligible for inclusion in
the review. A total of 20 studies (154 female patients) met the inclusion criteria (4
cohort studies, 1 case series, and 15 case reports). The NPWT system was used
alone in 17 patients and in combination with other techniques in the remaining 137.
The lesion was secondary to plastic surgery in 107 women, other operations in 40
women (38 of them for breast cancer), and primary breast infection in 7 women.
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Infections (including necrotizing fasciitis), pyoderma gangrenosum, and necrosis

were among the most common complications for which NPWT was used. In total,
150 of 154 patients receiving NPWT healed completely. Two patients died before
complete closure for reasons unrelated to the wound, and NPWT failed in 2
patients who healed later with muscle flap coverage. The authors concluded that
the scant published evidence suggested that NPWT systems might be useful in the
healing of complicated breast wounds. However, they stated that larger studies are
needed to investigate the effectiveness of this system further before it is
established in breast surgery.
The literature on the use of NPWT in surgical wounds has focused on its use in
wound complications. There is only scant literature on the use of NPWT in
preventing complications in surgical wounds of the abdomen based upon presence
of diabetes or obesity as risk factors.
In a pilot study, Mark et al (2013) assessed the effectiveness of incisional negative

pressure therapy in decreasing post-operative wound complications when placed
prophylactically over clean, closed incisions following cesarean section in obese
patients. This was a retrospective cohort study comparing rates of wound
complications following Cesarean sections in morbidly obese women prior to and
following the institution of standard use of prophylactic incisional negative pressure
therapy. All women with a body mass index (BMI) greater than 45 kg/m2
undergoing cesarean section in a 2-year period in a single institution were
included. The exposure was incisional negative pressure therapy, which began in
September 2009, versus standard wound dressing used in the previous year. The
main outcome was wound complication identified by ICD-9 codes. Demographic
and wound outcomes were compared with χ2 and t tests. Stata version 11.0 was
used for all analysis. A total of 63 women met the inclusion criteria, 21 of whom
received NPWT. The historical comparison and exposure groups were similar in all
characteristics studied with the exceptions of length of surgery (64 versus 76
minutes, p = 0.03), length of labor (78 versus 261 minutes, p = 0.02), scheduled
versus non-scheduled (77 % versus 52 %, p = 0.04), and mean age (29.5 versus
26.1 years, p = 0.04), respectively. There were 5 wound complications in the
control group (10.4 %) and none (0 %) in the study group (p = 0.15). The authors
concluded that the findings of this pilot study suggested a decrease in wound
complications in morbidly obese women receiving incisional negative pressure
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therapy following Cesarean section. The main drawbacks of this study were its
retrospective nature and its small sample size (n = 21 for women receiving NPWT).
These preliminary findings need to be validated by well-designed studies.
Schlatterer et al (2015) stated that evidence-based practice guidelines are limited

for use of NPWT in Grade IIIB tibia fractures (by definition required soft tissue
procedures). These investigators performed a systematic literature review of
NPWT in Grade IIIB tibia fractures in an attempt to substantiate current use and
guide future studies. They sought to answer the following: (i) Does the use of
NPWT compared with gauze dressings lead to fewer infections? (ii) Does it allow
flap procedures to be performed safely beyond 72 hours without increased
infection rates? And (iii) Is it associated with fewer local or free flap
procedures? These researchers conducted a systematic review of 6 large
databases (through September 1, 2013) for studies reporting use of NPWT in
Grade IIIB open tibia fractures, including information regarding infection rates and
soft tissue reconstruction. The systematic review identified 1 RCT and 12
retrospective studies: 4 studies compared infection rates between BPWT and
gauze dressings, 10 addressed infection rates with extended use, and 6 reported
on flap coverage rates in relation to NPWT use beyond 72 hours. None of the 13
studies was eliminated owing to lack of study quality. Negative pressure wound
therapy showed a decrease in infection rates over rates for gauze dressings in 2 of
4 studies (5.4 % [2 of 35] versus 28 % [7 of 25], and 8.4 % [14 of 166] versus 20.6
% [13 of 63]), an equivalent infection rate in 1 study (15 % [8 of 53] versus 14 % [5
of 16]), and an increased infection rate in the 4th study (29.5 % [23 of 78] versus 8
% [2 of 25]). In terms of the second question regarding infection rates with NPWT
beyond 72 hours, 8 of 10 studies concluded there was no increase in infection
rates, whereas 2 of 10 reported an increase in infection rates associated with
NPWT use beyond 72 hours. Infection rates varied from 0 % to 57 % in these 10
studies. Five studies reported low infection rates of 0 % to 7 % and 5 reported
rates of 27 % to 57 %. The third question (addressed by 6 studies) regarded the
potential decreased use of a soft tissue flap in patients treated with extended
NPWT. Flap rates were reduced by 13 % to 60 %, respectively compared with
those of historical controls. The patients in these 6 studies had Grade IIIB tibia
fractures after the first debridement. However, after extended NPWT, fewer
patients required flaps than grading at the first debridement would have predicted.
The authors concluded that there is an increasing body of data supporting NPWT
as an adjunctive modality at all stages of treatment for Grade IIIB tibia fractures.
There is an association between decreased infection rates with NPWT compared
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with gauze dressings. There is evidence to support NPWT beyond 72 hours

without increased infection rates and to support a reduction in flap rates with
NPWT. However, they stated that NPWT use for Grade IIIB tibia fractures requires
extensive additional study.
Echebiri et al (2015) evaluated the economic benefit of prophylactic NPWT on a

closed laparotomy incision after cesarean delivery in comparison with standard
post-operative dressing. These researchers designed a decision-analytic model
from a third-party payer's perspective to determine the cost-benefit of prophylactic
application of NPWT compared with standard post-operative dressing on a closed
laparotomy incision after cesarean delivery. The primary outcome measure was
the expected value of the cost per strategy. Baseline probabilities and cost
assumptions were derived from published literature. These investigators conducted
sensitivity analyses using both deterministic and probabilistic models. Cost
estimates reflect 2014 U.S. dollars. Under the baseline parameters, standard post-
operative dressing was the preferred strategy. Standard post-operative dressing
and prophylactic NPWT cost $547 and $804 per strategy, respectively. Sensitivity
analyses showed that prophylactic NPWT can be cost-beneficial if it is priced below
$192; standard post-operative dressing is the preferred strategy among patients
with surgical site infection rate of 14 % or less. If surgical site infection rates are
greater than 14 %, prophylactic NPWT could be cost-beneficial depending on the
degree of reduction in surgical site infections. At a surgical site infection rate of 30
%, the rate must be reduced by 15 % for NPWT to become the preferred strategy.
Monte Carlo simulation of 1,000 patients in 1 million trials showed that standard post-
operative dressing was the preferred cost-beneficial strategy with a frequency of 85
%. The authors concluded that their cost-benefit analysis provided economic
evidence suggesting that NPWT should not be used on closed laparotomy incisions
of patients with low risk of post-cesarean delivery surgical site infections. However,
among patients with a high risk of surgical site infections, prophylactic NPWT is
potentially cost-beneficial. Moreover, the authors stated that “additional studies,
including RCTs, are needed to establish the effectiveness of NPWT on incisions
intended to heal by primary intention”.
In an editorial that accompanied the afore-mentioned study, Rouse (2015) stated

that “The question that needs to be answered first is whether negative pressure
therapy has any efficacy; that is, does it reduce the rate of surgical site infection or
improve other important health outcomes when applied as a primary wound
dressing to women who have undergone cesarean delivery? Right now, there is no
Page 23 of 68
way to answer this question. We therefore should not assume, however

conditionally, that among patients with a high risk of surgical site infections,
prophylactic negative pressure wound therapy is potentially cost-effective ….
Absent compelling trial results, it is baffling why any insurance company would or
should pay for such therapy”.
Prophylactic Negative Pressure Wound Therapy After Ventral Hernia Repairs
Soares and colleagues (2015) stated that prophylactic incisional NPWT following
ventral hernia repairs (VHRs) remains controversial. These researchers evaluated
the impact of a modified NPWT system (hybrid-VAC or HVAC) on outcomes of
open VHR. A 5-year retrospective analysis of all VHRs performed by a single
surgeon at a single institution compared outcomes after HVAC versus standard
wound dressings. Multi-variable logistic regression compared surgical site
infections, surgical site occurrences, morbidity, and re-operation rates. These
investigators evaluated 199 patients (115 HVAC versus 84 standard wound
dressing patients). Mean follow-up was 9 months. The HVAC cohort had lower
surgical site infections (9 % versus 32 %, p < 0.001) and surgical site occurrences
(17 % versus 42 %, p = 0.001) rates. Rates of major morbidity (19 % versus 31 %,
p = 0.04) and 90-day reoperation (5 % versus 14 %, p = 0.02) were lower in the
HVAC cohort. The authors concluded that the HVAC system is associated with
optimized outcomes following open VHR. They stated that prospective studies
should validate these findings and define the economic implications of this
intervention.
Rodriguez-Unda and associates (2015) noted that despite improved operative

techniques, open VHR surgery in high-risk, potentially contaminated patients
remains challenging. As previously reported by this group of researchers, the use
of a modified NPWT system (hybrid-VAC or HVAC) in patients with grade 2 hernias
is associated with lower surgical site occurrence (SSO) and surgical site infection
(SSI) rates. Accordingly, these investigators examined if the HVAC would similarly
improve surgical site outcomes following VHR in patients with grade 3 hernias. A
4-year retrospective review (2011 to 2014) was conducted of all consecutive,
modified ventral hernia working group (VHWG) grade 3 hernia repairs with HVAC
closure performed by a single surgeon (FEE) at a single institution. Operative data
and 90-day outcomes were evaluated. Overall outcomes (e.g., recurrence, re-
operation, mortality) were reviewed for the study group. A total of 117 patients with
an average age of 56.7 ± 11.9 years were classified as grade 3 hernias and
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underwent open VHR with subsequent HVAC closure; 50 patients were male (42.7
%), the mean BMI was 35.2 (± 9.5), and 60.7 % had a history of prior hernia repair.
The average fascial defect size was 201.5 (± 167.3) cm(2) and the mean length of
stay was 14.2 (± 9.3) days; 90-day outcomes showed an SSO rate of 20.7 % and
an SSI rate of 5.2 %. The overall hernia recurrence rate was 4.2 % (n = 6) with a
mean follow-up of 11 ± 7.3 months. The authors concluded that modified VHWG
grade 3 ventral hernias are associated with significant morbidity. In this series
utilizing the HVAC system after VHR, the observed rate of SSO and SSI compared
favorably to reported series. They stated that further prospective cost-effective
studies are needed to validate these findings.
Intermittent-Instillation NPWT
Dale and Saeed (2015) noted that the use of NPWT with instillation (NPWTi) in
complex or difficult-to-treat acute and chronic wounds has expanded rapidly since
the introduction of commercially available NPWTi systems. These researchers
summarized the evidence related to NPWTi and particularly focus on the
application of this technology in diabetic foot ulcers, diabetic foot infections and post-
operative diabetic wounds. The benefits of NPWT are well-documented in the
treatment of complex acute and chronic wounds, including non-infected post-
operative diabetic wounds and diabetic foot ulcers. Combining intermittent wound
irrigation with NPWT may offer additional benefits compared to NPWT alone,
including further reduction of wound bed bio-burden, increased granulation tissue
formation and provision of wound irrigation in a sealed environment, thus
preventing potential cross-contamination events. Recently, available evidence
suggested that adjunctive NPWTi may be superior to standard NPWT in the
management of diabetic infections following surgical debridement and may promote
granulation tissue formation in slow-to-heal wounds. The authors concluded that
available evidence relating to the utilization of NPWTi in diabetic foot infections is
promising but limited in quality, being derived mostly from case series or small
retrospective or prospective studies. They stated that in order to confirm or refute
the potential benefits of NPWTi in this patient cohort, well-designed RCTs are
needed that compare NPWTi to NPWT or standard wound care methodologies.
Kim et al (2015) noted that NPWTi is a novel treatment option that provides the
combination of negative pressure with intermittent instillation of a solution.
Standard NPWT is an established adjunctive treatment option that offers the ability
to promote granulation tissue in wounds. However, there is limited evidence for its
Page 25 of 68
utility in the environment of active or senescent infection. Wounds that are acutely
infected or that contain deleterious biofilm are a challenging problem, which require
an intensive multi-modal approach including antibiosis, surgical intervention, and
local wound care. Adjunctive application of NPWTi can potentially expedite
clearance of infection and wound closure. Although this technology has been
commercially available for over 10 years, its adoption has been limited. Recently,
there has been a resurgence of interest in this therapy with emerging evidence from
animal models as well as human clinical studies. The authors concluded that there
are remaining questions regarding NPWTi including the selection of the optimal
instillation solution and device settings.
Gupta et al (2016) stated that NPWT is a well-established advanced therapy that

has been successful in adjunctive management of acute and chronic wounds. In
recent years, the introduction of topical wound solution delivery in combination with
NPWT has provided further benefits to wound healing. A commercially available
system now offers automated, volumetric control of instilled topical wound solutions
with a dwell time in combination with NPWT (NPWTi-d; V.A.C. VeraFlo™ Therapy,
KCI, an Acelity company, San Antonio, TX). This NPWTi-d system differs from
other instillation systems in that a timed, pre-determined volume of topical wound
solution is intermittently delivered (versus continuously fed) and allowed to dwell in
the wound bed (without NPWT), for a user-selected period of time before NPWT is
resumed. This added accuracy and process simplification of solution delivery in
tandem with NPWT have prompted use of NPWTi-d as first-line therapy in a wider
subset of complex wounds. However, considerably more research is needed to
validate effectiveness of NPWTi-d in various wound types. These investigators
provided a relevant overview of wound healing; described current literature
supporting the adjunctive use of NPWTi-d; proposed a clinical approach for
appropriate application of NPWTi-d; and concluded with case studies
demonstrating successful use of NPWTi-d. The authors concluded that either a
large case series examining effects of NPWTi-d on different wound types or
possibly a large prospective registry evaluating NPWTi-d with real-world topical
wound solutions versus immediate debridement and closure would be valuable to
the medical community in evaluating the effectiveness of this promising therapy.
Burn Wounds
Page 26 of 68
Fischer and associates (2016) stated that the use of NPWT is associated with
improved outcomes in smaller burns. These investigators reported their experience
using extra-large (XL) NPWT dressings to treat greater than or equal to 15 % total
body surface area (TBSA) burned and described their technique and early
outcomes. They also provided NPWT exudate volume for predictive fluid
resuscitation in these critically ill patients. These researchers retrospectively
reviewed patients treated with XL-NPWT from 2012 to 2014. Following
excision/grafting, graft and donor sites were sealed with a layered NPWT dressing.
They documented wound size, dressing size, NPWT outputs, graft take, wound
infections, and length of stay (LOS). Mean NPWT exudate volume per %TBSA per
day was calculated. A total of 12 burn patients (mean TBSA burned 30 %, range of
15 to 60 %) were treated with XL-NPWT (dressing TBSA burned and skin graft
donor sites range 17 to 44 %). Average graft take was 97 %; no wound infections
occurred; 2 patients had burns greater than or equal to 50 % TBSA and their LOS
was reduced compared to ABA averages. XL-NPWT outputs peaked at day 1 after
grafting followed by a steady decline until dressings were removed. Average XL-
NPWT dressing output during the first 5 days was 101 ± 66 ml/%BSA covered per
day; 2 patients developed acute kidney injury. The authors concluded that the use
of XL-NPWT to treat extensive burns is feasible with attention to application
technique; NPWT dressings appeared to improve graft take, and to decrease risk of
infection, LOS, and pain and anxiety associated with wound care. Measured fluid
losses can improve patient care in future applications of NPWT to large burn
wounds.
Kantak and colleagues (2016) stated that negative pressure has been employed in
various aspects of burn care and these investigators evaluated the evidence for
each of those uses. The PubMed and Cochrane CENTRAL databases were
queried for articles in the following areas: negative pressure as a dressing for acute
burns, intermediate treatment prior to skin grafting, bolster for skin autografts,
dressing for integration of dermal substitutes, dressing for skin graft donor sites, and
integrated dressing in large burns. A total of 15 studies met inclusion criteria; 1
study showed NPWT improved perfusion in acute partial-thickness burns, 8 out of 9
studies showed benefits when used as a skin graft bolster dressing, 1 out of 2
studies showed improved rate of re-vascularization when used over dermal
substitutes, and 1 study showed increased rate of re-epithelialization when used
over skin graft donor sites. The authors concluded that negative pressure can
improve autograft take when used as a bolster dressing. There is limited data to
suggest that it may also improve the rate of re-vascularization of dermal substitutes
Page 27 of 68
and promote re-epithelialization of skin graft donor sites. Other uses suggested by
studies that did not meet inclusion criteria include improving vascularity in acute
partial-thickness burns and as an integrated dressing for the management of large
burns. They stated that further studies are needed for most clinical applications to
establish negative pressure as an effective adjunct in burn wound care.
Following Cardiac Surgery
Santarpino and colleagues (2015) stated that bilateral internal thoracic artery
(BITA) grafting may be associated with a higher risk of post-operative deep sternal
wound infection than monolateral internal thoracic artery grafting due to a limited
blood supply to the thoracic chest wall. Because preliminary studies suggested
NPWT may reduce the risk of infection, a retrospective chart review of 129 patients
who underwent BITA between February 2003 and October 2014 was conducted.
Of those, 21 patients received NPWT for 5 days immediately following surgery and
the incisions of 108 patients were covered with a conventional gauze dressing.
Patient demographic and history variables as well as surgical procedure and
outcome variables were abstracted. Outcome variables assessed included
infection, need for transfusion, and length of hospital stay. The NPWT group was
significantly younger (average age of 55.9 ± 7.6 versus 60 ± 10.5 years, p = 0.049),
had fewer urgent/emergent surgeries (4 [19 %] versus 36 [33.3 %], p = 0.247), and
had significantly lower surgical risk scores (2.0 ± 2.3 versus 3.8 ± 2.8, p = 0.010).
The rate of deep sternal wound infections was lower in the NPWT than in the
control group, but the difference was not statistically significant (0 % versus 5.6 %,
p = 0.336). Sternal instability was noted in 4 control patients, requiring wound re-
exploration versus 0 in the NPWT group (3.7 % versus 0 %, p = 0.487); 1 patient in
the NPWT group had post-operative bleeding that required removal of the device.
The rates of re-thoracotomy due to bleeding were 9.3 % in the control compared to
4.8 % in the NPWT group (p = 0.435), which translated into a greater need for
blood transfusions (1.77 ± 3.4 units versus 0.3 3± 0.7 units, p = 0.056) and larger
chest drainage volume (997.8 ± 710 ml versus 591.2 ± 346 ml, p = 0.012) in the
control group. Hospital stay was longer in the control group, but the difference was
not statistically significant (12 ± 8.8 days versus 9.4 ± 4.2 days, p = 0.184). The
authors concluded that these preliminary results were encouraging, and
prospective RCTs to compare the efficacy, effectiveness, and cost-effectiveness of
NPWT to other wound management modalities following cardiac surgery are
needed.
Page 28 of 68
Following Knee Arthroplasty
In a RCT, Manoharan and colleagues (2016) evaluated the effect of NPWT on

quality of life (QoL), wound complications, and cost after primary knee arthroplasty.
This was a prospective analysis of 33 patients undergoing primary knee
arthroplasty performed by 3 surgeons in 1 institution. The first 12 patients (3
bilateral and 9 unilateral) had conventional dry dressings (CDD) applied and cost of
dressings was assessed. The other 21 patients all underwent bilateral knee
arthroplasty and had either side randomized to receiving NPWT or CDD. Cost of
dressings, wound complications, and QoL were compared. One patient had a
reaction to the NPWT requiring re-admission. Another had persistent wound
drainage that required NPWT application. There were no wound issues in the
remaining 31 patients. The average cost in the first 12 patients was Australian
dollar $48.70 with an average of 1.5 changes on ward. In the 21 patients receiving
both dressings, the average cost for CDD was less (Australian dollar $43.51 versus
$396.02, p ≤ 0.011, effect size [ES] = 1.06). When comparing QoL factors, wound
leakage (0.14 versus 0.39, p = 0.019, ES = 1.02), and wound protection (0.16
versus 0.33, p = 0.001, ES = 0.021) were better in the NPWT group. There was no
other significant difference in QoL factors. The average number of changes on the
ward was less for the NPWT group (1.19 versus 1.38, p = 0.317, ES = 1.02). The
authors found no benefit in wound healing or cost with NPWT following knee
arthroplasty. There was some benefit in NPWT QoL factors less wound leakage
and better protection.
Kidney Transplant Recipients
Shrestha and colleagues (2016) reviewed NPWT as an addition to the conventional

methods of wound management in kidney transplant recipients. A systematic
review, performed by searching the PubMed, Embase and Cochrane Library
databases, showed 11 case reports comprising a total of 22 kidney transplantation
(KT) patients (range of 1 to 9), who were treated with NPWT. Application of NPWT
was associated with successful healing of wounds, leg ulcer, lymphocele and urine
leak from ileal conduit. No complications related to NPWT were reported.
However, there was paucity of robust data on the effectiveness of NPWT in KT
recipients; therefore, prospective studies evaluating the safety and effectiveness of
NPWT and randomized trials comparing the effectiveness of NPWT with alternative
modalities of wound management in KT recipients is recommended. The authors
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concluded that negative pressure incision management system, NPWT with

instillation and endoscopic vacuum-assisted closure system are in investigational
stage.
Reduction of Surgical Site Infections Following Resection of Intra-Abdominal

Malignancies
Shen and colleagues (2017) noted that surgical site infections (SSI) remain a major
source of morbidity and cost following resection of intra-abdominal malignancies;
and NPWT has been reported to significantly decrease SSI when applied to the
closed laparotomy incision. These investigators reported results of a randomized,
phase II clinical trial, clinical trial examining the effect of NPWT on SSI rates in
surgical oncology patients with increased risk for infectious complications. From
2012 to 2016, a total of 265 patients underwent open resection of intra-abdominal
neoplasms were stratified into 3 groups: (i) gastro-intestinal (n = 57), (ii) pancreas
(n = 73), and (iii) peritoneal surface malignancy (n = 135). They were randomized
to NPWT or standard surgical dressing (SSD) applied to the incision from post-
operative day 1 through 4. Primary outcomes of combined incisional (superficial
and deep) SSI rates were assessed up to 30 days after surgery. There were no
significant differences in superficial SSI, 12.8 % versus 12.9 % (p => 0.99) or deep
SSI, 3.0 % versus 3.0 % (p => 0.99) rates between the SSD and NPWT groups,
respectively. When stratified by type of surgery there were still no differences in
combined incisional SSI rates for gastro-intestinal, 25 % versus 24 % (p => 0.99),
pancreas, 22 % versus 22 % (p => 0.99), and peritoneal surface malignancy, 9 %
versus 9 % (p => 0.99) patients. When performing univariate and multivariate
logistic regression analysis of demographic and operative factors for the
development of combined incisional SSI, the only independent predictors were pre-
operative albumin (p = 0.0031) and type of operation (p = 0.018). The authors
concluded that the use of NPWT did not significantly reduce incisional SSI rates in
patients having open resection of gastro-intestinal, pancreatic, or peritoneal surface
malignancies. They stated that based on these findings, NPWT cannot be currently
recommended as a therapeutic intervention to decrease infectious complications in
these patient populations.
Management of Closed Sternal Incision Following Thoracic Artery Grafting
Gatti and colleagues (2018) noted that single-use, closed incision management
(CIM) systems offer a practical means of delivering NPWT to patients. This
prospective study evaluates the Prevena Therapy system in a cohort of coronary
Page 30 of 68
patients at high-risk of deep sternal wound infection (DSWI). A total of 53

consecutive patients undergoing bilateral internal thoracic artery (BITA) grafting
were pre-operatively elected for CIM with the Prevena Therapy system, which was
applied immediately after surgery. The actual rate of DSWI in these patients was
compared with the expected risk of DSWI according to 2 scoring systems
specifically created to predict either DSWI after BITA grafting (Gatti score) or major
infections after cardiac surgery (Fowler score). The actual rate of DSWI was lower
than the expected risk of DSWI by the Gatti score (3.8 % versus 5.8 %, p = 0.047)
but higher than by the Fowler score (2.3 %, p = 0.069). However, while the Gatti
score showed very good calibration (χ2 = 4.8, p = 0.69) and discriminatory power
(area under the receiver-operating characteristic curve 0.838), the Fowler score
showed discrete calibration (χ2 = 10.5, p = 0.23) and low discriminatory power
(area under the receiver-operating characteristic curve 0.608). The authors
concluded that single-use CIM systems appeared to be useful to reduce the risk of
DSWI after BITA grafting. Moreover, they stated that more studies are needed to
make stronger this finding.
Management of Closed Sternal Incision Following Mammoplasty
In a prospective, randomized study, Tanaydin and associates (2018) compared

disposable NPWT with standard care in bilateral breast reduction mammoplasty
evaluating surgical site complications and scar quality. This trial included 32
patients who underwent bilateral breast reduction mammoplasty. Patients served
as their own control and received NPWT to one breast and fixation strips to the
other breast. The primary outcome was the number of wound healing
complications within 21 days when comparing NPWT treatment with fixation strips.
The secondary outcome was aesthetic appearance and quality of scarring using
questionnaires [VAS and Patient and Observer Scar Assessment Scale (POSAS)]
scored at day 42-, 90-, 180- and 365-day follow-up using additional scar
measurement modalities, such as viscoelasticity. For the 32 included patients, the
number of wound complications was significantly lower (p < 0.004) for the NPWT
treated sites compared to fixation strips. POSAS and VAS scores at 42 and 90
days revealed a significantly better quality of scarring in the NPWT treatment
breasts than in fixation strips. At 180-day follow-up, there was a significant
improvement in VAS scores, as well as a comparable improvement in POSAS
scores. No consistent significant improvement in scar quality was demonstrated
with the assays that were used. The authors concluded that the findings of this
study showed less wound healing complications and a statistically significant
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improvement in the aesthetic appearance and quality of scarring for the NPWT-
treated sites versus those breasts that received standard care with fixation strips.
The results indicated NPWT to be an attractive option for closed surgical incision
treatment. They noted that although the clinical significance of reduced scarring
may be not of utmost importance for the surgeon, it is imperative for the patient’s
emotional well-being and quality of life (QOL).
The authors stated that this study had several drawbacks. Given the nature of the
treatments, it was not possible to conduct a double-blind trial. Ideally, a control
group with the same non-activated device would have been better, but this would
still have been noted by the patient and physician. Therefore, investigator and
patient bias scoring POSAS and VAS could not be ruled out. The authors’ intention
was to at least blind the investigator, which was unsuccessful due to practical
reasons, e.g., the assessor was not available. Instead, the investigator did not
know the randomization schedule and the patients were asked not to reveal it. No
consistent significant improvement in scar viscoelasticity was demonstrated. This
could be due to measurements being performed with different probes and other
external factors influencing results. Even after standardizing measurement
locations, it proved difficult to exactly measure the same section of scar/skin during
follow-up. Moreover, some patients had such a fine scar that the probes were
overlapping onto normal skin. Although these researchers tried to keep a steady
room temperature and air humidity, thereby minimizing environmental factors, this
was practically impossible at the out-patient clinic. During the follow-up period,
seasons changed making the comparison of trans-epidermal water loss in serial
follow-ups difficult. Some patients were stressed because they were late or had put
on body lotion when they were not supposed to.
This was a small study (n = 32); its findings need to be validated by well-designed
studies.
Prophylaxis after Lower Extremity Fracture Surgery
In a prospective, case-series, pilot study, Dingemans and co-workers (2018)

examined the feasibility of a new portable single-use NPWT device in patients
undergoing major foot ankle surgery. Patients undergoing major foot ankle fracture
surgery at a single level 1 trauma center were eligible for this trial. Patient
characteristics were collected, as were fracture and surgical characteristics.
Primary outcome was surgical site infection (SSI) within 30 days as classified by
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the criteria from the Centers for Disease Control and Prevention (CDC). Patients in
the prospective cohort were case-matched with a historical cohort from the same
institution. A total of 60 patients were included. In 7 patients, the NPWT failed and
treatment was terminated. Mean age was 44 years and 85 % was American
Society of Anesthesiologists (ASA) 1; 43 % of the patients were actively smoking.
Indications for surgery were mid-foot, calcaneal, talar, and ankle fractures. In 53
patients, 4 (7.5 %) surgical site infections occurred, 2 superficial (3.3 %) and 2 (3.3
%) deep infections. For 47 patients, a match was available. The incidence of
surgical site infection did not statistically significantly differ between the prospective
cohort and retrospective matched cohort (4.3 % versus 14.9 %, p = 0.29,
respectively). This was also the case when looking at superficial and deep surgical
site infections separately (0 % versus 8.5 %, p = 0.08, and 4.3 % versus 6.4 %,
respectively). The authors concluded that they had observed surgical site
infections in 7.5 % of the patients with the use of prophylactic negative pressure
wound therapy. The incidence of surgical site infections was not statistically
significantly lower compared to a matched historical cohort. Moreover, they stated
that the results were promising and a larger study with adequate power could
provide more insight in the possible beneficial effect of prophylactic negative
pressure wound therapy; the results of this study can be used as a benchmark for
the development of a future prospective randomized study on NPWT.
The authors stated that this study had several drawbacks. First, these investigators
were unable to find an appropriate match for 2 patients with a superficial SSI. The
first patient (51-year old, actively smoking woman who had already experienced a
deep SSI following ORIF for a calcaneal fracture) underwent surgery for a
secondary arthrodesis through the ELA. From earlier research, the authors knew
that patients who have experienced a SSI prior to a secondary procedure are at risk
for developing a wound complication. For this reason, patients were matched on
this criterion when undergoing secondary procedures. However, as secondary
arthrodeses were not performed regularly, we were not able to identify a match for
this patient and therefore had to eliminate her from the analysis. For the second
patient (75-year old woman, non-smoking) with an ankle fracture, no match was
available either. These types of fractures were generally not treated in the authors’
tertiary referral university hospital. As a result, the number of patients available for
matching was low. The fact that these 2 patients were not included in the matching
analysis should be noticed, and the results should be interpreted with care.
Second, although matching for several factors, which were recognized for being
influential on the development of wound complications, it could not be ruled out that
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residual confounding exist through factors not matched for. Third, it must be noted
that the time span of the historical cohort from which the patients were drawn was
16 years. During these 16 years, major changes in treatment insights may have
developed. As a result of this, the SSI rate in the control group may be higher than
what could be expected using contemporary techniques; this should be kept in
mind when interpreting the results from the matched cohorts. Lastly, the authors
did not compare wound dehiscence among the 2 groups. They observed 3 cases
of wound dehiscence in this case-series study. However, as these researchers
collected data on the matching database retrospectively, they felt that they could
not reliably identify all cases of wound dehiscence in this group. For this reason,
they chose not to compare the incidence of wound dehiscence between the 2
groups. It is well recognized that the incidence of complications is lower in
retrospective studies due to insufficient documentation of complications. Thus,
possible wound complications in patients in the matching database may not have
been identified, and the incidence in the control may be higher.
Management of Fasciotomy Wounds in Persons with Compartment

Syndrome
Cone and Inaba (2017) noted that lower extremity compartment syndrome is a
devastating complication if not rapidly diagnosed and properly managed. The
classic symptoms of compartment syndrome can be deceiving as they occur late.
Any concern for compartment syndrome based on mechanism, or the presence of
pain in the affected extremity, should prompt a compartment pressure check. Both
absolute compartment pressures above 30 mm Hg and a pressure differential of
less than 30 mm Hg are used to make the diagnosis. The treatment goal is first to
save the patient’s life and second to salvage the affected limb. Fasciotomy is the
only accepted treatment of compartment syndrome and should be performed
quickly after the diagnosis is made. Outcomes after fasciotomy are best when
there is no delay in treatment. These investigators stated that there is evidence
that the use of a vacuum-assisted closure dressing is associated with significantly
higher rates of primary closure than traditional dressings.
Jauregui and colleagues (2017) stated that currently there is no consensus

regarding which technique should be used when closing fasciotomy incisions.
Wound closure technique is based on the surgeon’s preference and the
requirements of each clinical scenario. These investigators conducted a systematic
literature review to evaluate the current evidence regarding fasciotomy closure
Page 34 of 68
techniques. The objectives of this study were to determine the current techniques
available for fasciotomy wound closure; assess the overall success of these
techniques in achieving wound closure in the extremities; and examine the
effectiveness of these techniques in minimizing the time needed for fasciotomy
wound closure and complication rates. These researchers found that after
evaluating 23 studies, they determined that the highest success rate was observed
for dynamic dermato-traction (93 %) and gradual suture approximation (92 %),
followed by VAC (78 %). However, VAC had the lowest complication rate (2 %),
followed by gradual suture approximation (15 %), and then dynamic dermato-
traction (18 %). The authors concluded that that currently there are many surgeons
who prefer VAC systems. In this meta-analysis, VAC systems had the lowest
success rate but also had the lowest complication rate. In this study, defining
success as closure without STSG may not be an accurate representation of what a
surgeon deems successful, following a severe extremity injury requiring
fasciotomies. Furthermore, in a patient who is already at high risk for complications
due to the severe nature of the injury that lead to ACS, VAC systems may be the
best choice.
The American Academy of Orthopedic Surgeons (AAOS, 2018) had a qualified

recommendation for NPWT for compartment syndrome.
Furthermore, an UpToDate review on “Patient management following extremity

fasciotomy” (Modrall, 2019) states that “We use saline gauze dressings in the
immediate postoperative period to allow frequent wound evaluation and interval
debridement of necrotic tissue, as needed. Once the fasciotomy wounds are stable,
we use active tension (e.g., shoelace technique) with negative pressure wound
therapy (NPWT) to facilitate fasciotomy closure”.
Prophylactic Negative-Pressure Wound Therapy After Cesarean Delivery
In a systematic review and meta-analysis, Yu and colleagues (2018) examined the

effect of prophylactic NPWT on surgical site infections and other wound
complications in women after cesarean delivery. These investigators searched
Ovid Medline, Embase, SCOPUS, Cochrane Database of Systematic Reviews, and
ClinicalTrials.gov. They included RCTs and observational studies comparing
prophylactic NPWT with standard wound dressing for cesarean delivery. The
primary outcome was surgical site infection after cesarean delivery; secondary
outcomes were composite wound complications, wound dehiscence, wound
Page 35 of 68
seroma, endometritis, and hospital re-admission. Heterogeneity was assessed

using Higgin's I2; RRs with 95 % CIs were calculated using random-effects
models. A total of 6 RCTs and 3 cohort studies in high-risk mostly obese women
met inclusion criteria and were included in the meta-analysis; 6 were full-text
articles, 2 published abstracts, and 1 report of trial results in ClinicalTrials.gov.
Studies were also heterogeneous in the patients included and type of NPWT
device. The risk of surgical site infection was significantly lower with the use of
prophylactic NPWT compared with standard wound dressing (7 studies: pooled RR,
0.45; 95 % CI: 0.31 to 0.66; adjusted RR, -6.0 %, 95 % CI: -10.0 % to -3.0 %;
number needed to treat, 17, 95 % CI: 10 to 34). There was no evidence of
significant statistical heterogeneity (I2 = 9.9 %) or publication bias (Egger p =
0.532). Of the secondary outcomes, only composite wound complications were
significantly reduced in patients receiving prophylactic NPWT compared with
standard dressing (9 studies: pooled RR, 0.68, 95 % CI: 0.49 to 0.94). The authors
concluded that studies on the effectiveness of prophylactic NPWT at cesarean
delivery were heterogeneous; but suggested a reduction in surgical site infection
and overall wound complications. Moreover, these researchers stated that larger
definitive trials are needed to clarify the clinical utility of prophylactic NPWT after
cesarean delivery.
In a cost-effectiveness analysis conducted alongside a clinical trial, Hyldig and

associates (2019) evaluated the cost-effectiveness of incisional NPWT (iNPWT) in
preventing SSI in obese women after caesarean section. Subjects were women
with a pre-gestational body mass index (BMI) of greater than or equal to 30 kg/m2.
These investigators used data from a RCT of 876 obese women who underwent
elective or emergency caesarean section and were subsequently treated with
iNPWT (n = 432) or a standard dressing (n = 444). Costs were estimated using
data from 4 Danish National databases and analyzed from a healthcare perspective
with a time horizon of 3 months after birth. Main outcome measures were cost-
effectiveness based on incremental cost per surgical site infection avoided and per
quality-adjusted life-year (QALY) gained. The total healthcare costs per woman
were €5,793.60 for iNPWT and €5,840.89 for standard dressings. Incisional NPWT
was the dominant strategy because it was both less expensive and more effective;
however, no statistically significant difference was found for costs or QALYs. At a
willingness-to-pay threshold of €30,000, the probability of the intervention being cost-
effective was 92.8 %. A subgroup analysis stratifying by BMI showed that the cost
saving of the intervention was mainly driven by the benefit to women with a pre-
pregnancy BMI greater than or equal to 35 kg/m2. The authors concluded that
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incisional NPWT appeared to be cost saving compared with standard dressings;

however this finding was not statistically significant. The cost savings were
primarily found in women with a pre-pregnancy BMI greater than or equal to 35
kg/m2.
Tuuli (2019) stated that prophylactic NPWT has emerged as a promising

intervention in patients at high risk for SSI. One such group is obese gravidae, a
growing population worldwide who are at high risk for both cesarean delivery and
SSI. Although the precise mechanism by which NPWT aids incisional wound
healing is unclear, experimental evidence suggested that it reduces bacterial
contamination, edema, and exudate, increases microvascular blood flow, promotes
formation of granulation tissue and reduces lateral tensile and shear stress. The
author noted that data on NPWT after cesarean have been limited to retrospective
cohort and small pilot RCTs. Whereas some studies demonstrated benefit in
reducing SSI and other wound complications, they were limited by small sample
sizes, selection bias and confounding factors.
Closed Groin Incisions in Arterial Surgery
Svensson-Bjork and colleagues (2019) noted that SSI following groin incisions in
arterial surgery is common and may lead to amputation or death. Incisional NPWT
dressings have been suggested to reduce SSIs. In a systematic review with meta-
analysis, these researchers examined the effects of incisional NPWT on the
incidence of SSI in closed groin incisions following arterial surgery. A study
protocol for this systematic review of RCTs was published in Prospero
(CRD42018090298) a priori, with pre-defined search, inclusion and exclusion
criteria. The records generated by the systematic research were screened for
relevance by title and abstract and in full text by 2 of the authors independently.
The selected articles were rated for bias according to the Cochrane risk-of-bias
tool. Among 1,567 records generated by the search, 7 RCTs were identified,
including 1,049 incisions. Meta-analysis showed a reduction in SSI with incisional
NPWT (odds ratio (OR) 0.35, 95 % CI: 0.24 to 0.50; p < 0.001). The heterogeneity
between the included studies was low (I2 = 0 %). The quality of evidence was
graded as moderate; 2 studies had multiple domains in the Cochrane risk-of-bias
tool rated as high risk of bias. A subgroup meta-analysis of 3 studies of lower limb re-
vascularization procedures only (363 incisions) demonstrated a similar reduction in
SSI (OR 0.37, 95 % CI: 0.22 to 0.63; p < 0.001; I2 = 0 %). The authors concluded
that incisional NPWT following groin incisions for arterial surgery
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reduced the incidence of SSI compared with standard wound dressings. Moreover,
they stated that the risk of bias highlighted the need for a high-quality RCT with cost-
effectiveness analysis.
Open Fracture / Traumatic Wounds
In a Cochrane review, Iheozor-Ejiofor and colleagues (2018) examined the effects

of NPWT for treating open traumatic wounds in people managed in any care
setting. In June 2018, these investigators searched the Cochrane Wounds
Specialized Register, the Cochrane Central Register of Controlled Trials
(CENTRAL), Ovid Medline (including in-process and other non-indexed citations),
Ovid Embase and EBSCO CINAHL Plus. They also searched clinical trials
registries for ongoing and unpublished studies, and scanned reference lists of
relevant included studies as well as reviews, meta-analyses and health technology
reports to identify additional studies. There were no restrictions with respect to
language, date of publication or study setting. Published and unpublished RCTs
that used NPWT for open traumatic wounds involving either open fractures or soft
tissue wounds were selected for analysis; primary outcomes were wound healing,
wound infection and adverse events (AEs). Two review authors independently
selected eligible studies, extracted data, carried out a “risk of bias” assessment and
rated the certainty of the evidence. Data were presented and analyzed separately
for open fracture wounds and other open traumatic wounds (not involving a broken
bone). A total of 7 RCTs (1,377 participants recruited) met the inclusion criteria of
this review. Study sample sizes ranged from 40 to 586 participants; 1 study had 3
arms, which were all included in the review; 6 studies compared NPWT at 125
mmHg with standard care: 1 of these studies did not report any relevant outcome
data; 1 further study compared NPWT at 75 mmHg with standard care and NPWT
125 mmHg with NPWT 75 mmHg. Open fracture wounds (4 studies all comparing
NPWT 125 mmHg with standard care); 1 study (460 participants) comparing NPWT
125 mmHg with standard care reported the proportions of wounds healed in each
arm. At 6 weeks there was no clear difference between groups in the number of
participants with a healed, open fracture wound: RR 1.01 (95 % CI: 0.81 to 1.27);
moderate-certainty evidence, down-graded for imprecision. These researchers
pooled data on wound infection from 4 studies (596 participants). Follow-up varied
between studies but was approximately 30 days. On average, it was uncertain
whether NPWT at 125 mmHg reduced the risk of wound infection compared with
standard care (RR 0.48, 95 % CI: 0.20 to 1.13; I2 = 56 %); very low-certainty
evidence down-graded for risk of bias, inconsistency and imprecision. Data from 1
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study showed that there was probably no clear difference in health-related QOL
between participants treated with NPWT 125 mmHg and those treated with
standard wound care (EQ-5D utility scores mean difference (MD) -0.01, 95 % CI:
-0.08 to 0.06; 364 participants, moderate-certainty evidence; physical component
summary score of the short-form 12 instrument MD -0.50, 95 % CI: -4.08 to 3.08;
329 participants; low-certainty evidence down-graded for imprecision). Moderate-
certainty evidence from 1 trial (460 participants) suggested that NPWT was unlikely
to be a cost-effective treatment for open fractures in the United Kingdom. On
average, NPWT was more costly and conferred few additional QALYs when
compared with standard care. The incremental cost-effectiveness ratio was GBP
267,910 and NPWT was shown to be unlikely to be cost effective at a range of
cost-per-QALYs thresholds. These investigators down-graded the certainty of the
evidence for imprecision. Other open traumatic wounds (2 studies, 1 comparing
NPWT 125 mmHg with standard care and a 3-arm study comparing NPWT 125
mmHg, NPWT 75 mmHg and standard care). Pooled data from 2 studies (509
participants) suggested no clear difference in risk of wound infection between open
traumatic wounds treated with NPWT at 125 mmHg or standard care (RR 0.61, 95
% CI: 0.31 to 1.18); low-certainty evidence down-graded for risk of bias and
imprecision; 1 trial with 463 participants compared NPWT at 75 mmHg with
standard care and with NPWT at 125 mmHg. Data on wound infection were
reported for each comparison. It was uncertain if there was a difference in risk of
wound infection between NPWT 75 mmHg and standard care (RR 0.44, 95 % CI:
0.17 to 1.10; 463 participants) and uncertain if there was a difference in risk of
wound infection between NPWT 75 mmHg and 125 mmHg (RR 1.04, 95 % CI: 0.31
to 3.51; 251 participants). These researchers down-graded the certainty of the
evidence for risk of bias and imprecision. The authors concluded that there was
moderate-certainty evidence for no clear difference between NPWT and standard
care on the proportion of wounds healed at 6 weeks for open fracture wounds.
There was moderate-certainty evidence that NPWT was not a cost-effective
treatment for open fracture wounds. Moderate-certainty evidence means that the
true effect is likely to be close to the estimate of the effect, but there is a possibility
that it is substantially different. It was uncertain whether there was a difference in
risk of wound infection, AEs, time-to-closure or coverage surgery, pain or health-
related QOL between NPWT and standard care for any type of open traumatic
wound.
Post-Operative Transgender Surgeries to Improve Wound Healing
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The World Professional Association for Transgender Health (WPATH)’s “Standards

of Care for the Health of Transsexual, Transgender, and Gender Nonconforming
People, 7th Version (Coleman et al, 2012) did not mention NPWT for post-operative
care.
Furthermore, UpToDate reviews on “Negative pressure wound therapy” (Gestring,

2019), “Transgender surgery: Male to female” (Ferrando and Thomas, 2019), and
“Transgender surgery: Female to male” (Ferrando et al, 2019) do not mention
NPWT as a management option for post-operative transgender surgeries to
improve wound healing.
Appendix
Specifications of Equipment and Supplies
NPWT is provided with an integrated system of components. This system contains

a pump, dressing sets and a separate collection canister. Wound suction systems
that do not contain all of the required components are not classified as NPWT. See
below for component specifications.
For purposes of this policy, a NPWT pump describes a stationary or portable

Negative Pressure Wound Therapy (NPWT) electrical pump which provides
controlled subatmospheric pressure that is designed for use with NPWT
dressings and canisters to promote wound healing. The NPWT pump must be
capable of being selectively switched between continuous and intermittent modes
of operation and is controllable to adjust the degree of subatmospheric pressure
conveyed to the wound in a range of 40-80 mm Hg subatmospheric pressure. The
system must contain sensors and alarms to monitor pressure variations and
exudate volume in the collection canister.
A NPWT dressing kit describes an allowance for a dressing set which is used in
conjunction with a stationary or portable NPWT pump. A single dressing kit is used
for each single, complete dressing change, and contains all necessary
components, including but not limited to any separate, non-adherent porous
dressing(s), drainage tubing, and an occlusive dressing(s) which creates a seal
around the wound site for maintaining subatmospheric pressure at the wound.
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A NPWT collection cannister describes a canister set which is used in conjunction

with a stationary or portable NPWT pump and contains all necessary components,
including but not limited to a container to collect wound exudate. Canisters may be
various sizes to accommodate stationary or portable NPWT pumps.
Contraindications for Negative Pressure Wound Therapy (NPWT)
NPWT is contraindicated in the presence of any the following:
 Cancer present in the wound; or

 Inadequately debrided wounds; granulation tissue that will not form over
necrotic tissue; or
 Presence of untreated coagulopathy; or
 The presence in the wound of necrotic tissue with eschar, if debridement is not
attempted; or
 The presence of a fistula to an organ or body cavity within the vicinity of the
wound; or
 Untreated osteomyelitis or spesis within the vicinity of the wound.
List of Negative Pressure Wound Therapy (NPWT) Devices*
 ActiV.A.C.® Therapy Unit

 Engenex® Advanced NPWT System
 Exusdex® wound drainage pump
 EZCARE Negative Pressure Wound Therapy
 Genadyne A4 Wound Vacuum System
 InfoV.A.C.® Therapy Unit
 Invia Liberty Wound Therapy
 Invia Vario 18 ci Wound Therapy
 Medela® Invia Liberty pump
 Mini V.A.C.®
 NPD 1000 Negative Pressure Wound Therapy System
 Prodigy™ NPWT System (PMS-800 and PMS-800V)
 PRO-II™
 PRO-I™
 RENASYS™ EZ Negative Pressure Wound Therapy
 SVEDMAN™ and SVED™ Wound Treatment Systems
 V.A.C.® ATS™
Page 41 of 68
 V.A.C.® Freedom™
 V.A.C.® Instill Device
 V.A.C.® Therapy Unit
 V.A.C.® (Vacuum Assisted Closure™)
 V1STA Negative Pressure Wound Therapy
 Venturi™ Negative Pressure Wound Therapy
*
These devices have U.S. Food and Drug Administration 510(k) clearance for
marketing in the United States. This list is not all-inclusive.
Documentation Requirements
Information describing the history, previous treatment regimens (if applicable), and
current wound management for which an NPWT pump is being billed must be
present in the member’s medical record and be available for review upon request.
This documentation must include such elements as length of sessions of use,
dressing types and frequency of change, and changes in wound conditions,
including precise measurements, quantity of exudates, presence of granulation and
necrotic tissue and concurrent measures being addressed relevant to wound
therapy (debridement, nutritional concerns, support surfaces in use, positioning,
incontinence control, etc.).
Information describing the wound evaluation and treatment, recorded in the

member’s medical record, must indicate regular evaluation and treatment of the
beneficiary’s wounds, as detailed in the Policy Section. Documentation of
quantitative measurements of wound characteristics including wound length and
width (surface area), and depth, and amount of wound exudate (drainage),
indicating progress of healing must be entered at least monthly. The supplier of the
NPWT equipment and supplies must obtain from the treating clinician, an
assessment of wound healing progress, based upon the wound measurement as
documented in the member’s medical record, in order to determine whether the
equipment and supplies continue to be medically necessary. (The supplier need not
view the medical records in order to bill for continued use of NPWT. Whether the
supplier ascertains that wound healing is occurring from month to month via verbal
or written communication is left to the discretion of the supplier. However, the
member’s medical records may be requested in order to corroborate that wound
healing is/was occurring as represented on the supplier’s claims for
reimbursement.)
Page 42 of 68
When billing for NPWT, an ICD-9-CM diagnosis code (specific to the 5th digit or
narrative diagnosis), describing the wound being treated by NPWT, must be
included on each claim for the equipment and related supplies.
The medical record must include a statement from the treating physician describing
the initial condition of the wound (including measurements) and the efforts to
address all aspects of wound care listed in the Policy Section. For each subsequent
month, the medical record must include updated wound measurements and what
changes are being applied to effect wound healing. Month-to-month comparisons of
wound size must compare like measurements i.e. depth compared to depth or
surface area compared to surface area.
If the initiation of NPWT occurs during an inpatient stay, in order to accurately

account for the duration of treatment, the initial inpatient date of service must be
documented. This date must be available upon request.
When NPWT therapy exceeds 4 months on the most recent wound, individual
consideration for one additional month at a time may be sought using the appeals
process. Information from the treating physician’s medical record,
contemporaneous with each requested one-month treatment time period extension,
must be submitted with each appeal explaining the special circumstances
necessitating the extended month of therapy. Note, this policy provides coverage
for the use of NPWT limited to initiating healing of the problem wounds described in
the Policy Section section of this CPB rather than continuation of therapy to
complete healing since there is no published medical literature demonstrating
evidence of a clinical benefit for the use of NPWT to complete wound healing.
Therefore, general, vague or nonspecific statements in the medical record such as
“doing well, want to continue until healed” provide insufficient information to justify
the need for extension of treatment. The medical record must provide specific and
detailed information to explain the continuing problems with the wound, what
additional measures are being undertaken to address those problems and promote
healing and why a switch to alternative treatments alone is not possible.
When billing for quantities of canisters greater than those described in the Policy
Section as the usual maximum amounts, there must be clear and explicit
information in the medical record that justifies the additional quantities.
Page 43 of 68
CPT Codes / HCPCS Codes / ICD-10 Codes
Information in the [brackets] below has been added for clarification

purposes. Codes requiring a 7th character are represented by "+":
Code Code Description
CPT codes covered if selection criteria are met:
96574 Debridement of premalignant hyperkeratotic lesion(s) (ie, targeted
curettage, abrasion) followed with photodynamic therapy by external
application of light to destroy premalignant lesions of the skin and
adjacent mucosa with application and illumination/activation of
photosensitizing drug(s) provided by a physician or other qualified
health care
97605 Negative pressure wound therapy (eg, vacuum assisted drainage
collection), including topical application(s), wound assessment, and
instruction(s) for ongoing care, per session; total wound(s) surface area
less than or equal to 50 square centimeters
97606 total wound(s) surface area greater than 50 square centimeters
CPT codes not covered for indications listed in the CPB:
97607 Negative pressure wound therapy, (eg, vacuum assisted drainage
collection), utilizing disposable, non-durable medical equipment
including provision of exudate management collection system, topical
application(s), wound assessment, and instructions for ongoing care,
per session; total wound(s) surface area less than or equal to 50 square
centimeters
97608 total wound(s) surface area greater than 50 square centimeters
Other CPT codes related to the CPB:
11000 - 11047 Excision - debridement of skin, subcutaneous tissue, muscle and/or
fascia, bone
27445 Arthroplasty, knee, hinge prosthesis
27446 Arthroplasty, knee, condyle and plateau; medial OR lateral
compartment
27447 Arthroplasty, knee, condyle and plateau; medial AND lateral
compartments with or without patella resurfacing (total knee
arthroplasty)
Page 44 of 68
27500 - 27540, Lower extremity fracture surgery
27750 - 27828,
28400 - 28531
33010 - 37799 Cardiovascular system
50360 Renal allotransplantation, implantation of graft; without recipient
nephrectomy
50365 Renal allotransplantation, implantation of graft; with recipient
nephrectomy
50547 Laparoscopy, surgical; donor nephrectomy (including cold
preservation); from living donor
97597 - 97598 Debridement (eg, high pressure waterjet with/without suction, sharp
selective debdridement with scissors, scalpel and forceps), open
wound, (eg, fibrin, devitalized epidermis and/or dermis, exudate, debris,
biofilm), including topical application(s), wound assessment, use of a
whirlpool, when performed and instruction(s) for ongoing care, per
session, total wound(s) surface area
97602 Removal of devitalized tissue from wound(s), non-selective
debridement, without anesthesia (e.g., wet-to-moist dressings,
enzymatic, abrasion), including topical application(s), wound
assessment, and instruction(s) for ongoing care, per session
HCPCS codes covered if selection criteria are met:
A6550 Wound care set, for negative pressure wound therapy electrical pump,
includes all supplies and accessories
A9272 Wound suction, disposable, includes dressing, all accessories and
components, any type, each
E2402 Negative pressure wound therapy electrical pump, stationary or
portable
K0743 Suction pump, home model, portable, for use on wounds
K0744 Absorptive wound dressing for use with suction pump, home model,
portable pad size 16 square inches or less
portable pad size more than 16 square inches but less than or equal to
48 square inches
Page 45 of 68
portable, pad size greater than 48 square inches
Other HCPCS codes related to the CPB:
A7000 Canister, disposable, used with suction pump, each
J9000 - J9999 Chemotherapy drugs
ICD-10 codes covered if selection criteria are met:
E10.40 - E10.49 Diabetes with neurological manifestations [chronic Stage III or IV
E11.40 - E11.49 neuropathic ulcers (e.g., diabetic ulcer), venous or arterial insufficiency
E13.40 - E13.29 ulcer, or a chronic ulcer of mixed etiology present for at least 30 days
meeting specific criteria] [not covered for prophylactic use of NPWT in
preventing complications in surgical wounds of the abdomen based
upon presence of diabetes or obesity as risk factors]
E10.51 - E10.59 Diabetes with peripheral circulatory disorders [chronic Stage III or IV
E10.610 - E10.69 Diabetes with other specified manifestations [chronic Stage III or IV
I70.231 - I70.25 Atherosclerosis of native arteries of extremities with ulceration [chronic
Stage III or IV neuropathic ulcers (e.g., diabetic ulcer), venous or
arterial insufficiency ulcer, or a chronic ulcer of mixed etiology present
for at least 30 days meeting specific criteria]
I70.261 - I70.269 Atherosclerosis of native arteries of extremities with gangrene [chronic
Stage III or IV neuropathic ulcers (e.g., diabetic ulcer), venous or
arterial insufficiency ulcer, or a chronic ulcer of mixed etiology present
for at least 30 days meeting specific criteria]
Page 46 of 68
I73.9 Peripheral vascular disease, unspecified [chronic Stage III or IV
neuropathic ulcers (e.g., diabetic ulcer), venous or arterial insufficiency
ulcer, or a chronic ulcer of mixed etiology present for at least 30 days
meeting specific criteria]
I83.001 - I83.029 Varicose veins of lower extremities with ulcer [chronic Stage III or IV
neuropathic ulcers (e.g., diabetic ulcer), venous or arterial insufficiency
ulcer, or a chronic ulcer of mixed etiology present for at least 30 days
meeting specific criteria]
L02.01 - L03.90 Other cellulitis and abscess
Page 47 of 68
L89.003 L89.004, Pressure ulcer stage III or IV
L89.013 -
L89.014
L89.023 -
L89.024, L89.103
- L89.104
L89.113 -
L89.114, L89.123
- L89.124
L89.133 -
L89.134, L89.143
- L89.144
L89.153 -
L89.154, L89.203
- L89.204
L89.213 -
L89.214, L89.223
- L89.224
L89.303 -
L89.304, L89.313
- L89.314
L89.323 -
L89.324. L89.43 -
L89.44
L89.503 -
L89.504, L89.513
- L89.514
L89.523 -
L89.524, L89.603
- L89.604
L89.613 -
L89.614, L89.623
- L89.624
L89.813 -
L89.814, L89893
- L89.894
Page 48 of 68
S31.100+ - Open wound of abdominal wall
S31.159+
S31.600+ - Open wound of abdominal wall with penetration into peritoneal cavity
S31.659+
S39.001+, Other injury of abdomen [abdominal traumatic injuries]
S39.021,
S39.091+,
S39.81x+.
S39.91x+
Page 49 of 68
S41.021+ - Open wound of upper limb, complicated
S41.029+
S41.041+ -
S41.049+
S41.121+ -
S41.129+
S41.141+ -
S41.149+
S51.021+ -
S51.029+
S51.041+ -
S51.049+
S51.821+ -
S51.829+
S51.841+ -
S51.859+
S61.021+ -
S61.029+
S61.041+ -
S61.049+
S61.121+ -
S61.129+
S61.141+ -
S61.149+
S61.220+ -
S61.229+
S61.240+ -
S61.249+
S61.320+ -
S61.329+
S61.340+ -
S61.349+
S61.421+ -
S61.429+
S61.441+ -
S61.449+
Page 50 of 68
S61.521+ -
S61.529+
S71.021+ - Open wound of lower limb, complicated
S71.029+
S71.041+ -
S71.049+
S71.121+ -
S71.129+
S71.141+ -
S71.149+
S81.021+ -
S81.029+
S81.041+ -
S81.049+
S81.821+ -
S81.829+
S81.841+ -
S81.849+
T79.A0xA - Traumatic compartment syndrome
T79.A9xS
T81.31x+ - Disruption of external or internal operation (surgical) wound, not
T81.32x+ elsewhere classified
T81.40xA - Infection following a procedure [other than deep sternal wound
T81.49xS infections]
T81.89x+ Other complications of procedures, not elsewhere classified [other than
deep sternal wound infections]
ICD-10 codes not covered for indications listed in CPB (not all-inclusive):
E66.01 - E66.9 Overweight and obesity [prophylactic use of NPWT for preventing
complications in surgical wounds of the abdomen based upon presence
of diabetes or obesity as risk factors]
K43.0 - K43.9 Ventral hernia [not covered for prophylactic negative pressure wound
therapy after ventral hernia repairs]
L05.01 - L05.02 Pilonidal cyst with abscess
L05.91 - L05.92 Pilonidal cyst without abscess
Page 51 of 68
L89.000 - Chronic ulcer of skin [other than chronic stage III or stage IV pressure
L89.002, L89.009 ulcer, neuropathic ulcer (e.g., diabetic ulcer), venous or arterial
- L89.012 insufficiency ulcer, or a chronic ulcer of mixed etiology present for at
L89.019 - least 30 days]
L89.022, L89.029
- L89.102
L89.109 -
L89.112, L89.119
- L89.122
L89.129 -
L89.132, L89.139
- L89.142
L89.149 -
L89.152, L89.159
- L89.202
L89.209 -
L89.212, L89.219
- L89.222
L89.229 -
L89.302, L89.309
- L89.312
L89.319 -
L89.311, L89.329
- L89.42
L89.45 - L89.502,
L89.509 -
L89.512
L89.519 -
L89.522, L89.529
- L89.602
L89.609 -
L89.612, L89.619
- L89.622
L89.629 -
L89.812, L89.819
- L89.892
Page 52 of 68
L89.899 - L89.92,
L89.95,
L97.101 -
L97.929, L98.441
- L98.499
L91.0 Hypertrophic scar
O90.0 Disruption of cesarean delivery wound [prophylactic use of NPWT after
cesarean delivery]
S02.0xx+ - Open fractures [7th character B]
S02.92x+,
S12.000+ -
S12.691+,
S22.000+ -
S22.9xx+,
S32.000+ -
S32.9xx+,
S42.001+ -
S42.92x+,
S52.001+ -
S52.009+,
S62.001+ -
S62.92x+,
S72.001+ -
S72.466+,
S72.491+ -
S72.92x+,
S82.001+ -
S82.156+,
S82.191+ -
S82.309+,
S92.001+ -
S92.919+,
S99.001+ -
S99.929+
Page 53 of 68
S21.101+ - Open wound of chest (wall), complicated [deep sternal wound infection]
S21.109+
S21.121+ -
S21.129+
S21.141+ -
S21.149+
S82.101+ - Fracture of tibia
S82.399+
S89.001+ - Physeal fracture of tibia
S89.199+
T20.20x+ - Burns or corrosion of second degree of head, face and neck [partial-
T20.29x+ thickness]
T20.60x+ -
T20.69x+
T21.20x+ - Burns or corrosion of second degree of truck [partial-thickness]
T21.29x+T21.60x+
- T21.69x+
T22.20x+ - Burns or corrosion of second degree of shoulder and upper limb
T22.299+ [partial-thickness]
T22.60x+
-T22.699+
T23.201+ - Burns or corrosion of second degree of wrist and hand [partial-
T23.299+ thickness]
T23.601+ -
T23.699+
Z94.0 Kidney transplant status
Z95.810 - Presence of other cardiac implants and grafts [for use following cardiac
Z95.818 surgery]
Z96.651 - Presence of artificial knee joint
Z96.659
ICD-10 codes contraindicated for Negative Pressure Wound Therapy (NPWT):
C00.0 - C96.9 Malignant neoplasms [cancer present in wounds]
D00.00 - D09.9
Page 54 of 68
I96 Gangrene, not elsewhere classified [presence in the wound of necrotic
tissue with eschar if debridement is not attempted]
L08.9 Local infection of skin and subcutaneous tissue, unspecified [to an
organ or body cavity within the vicinity of the wound]
M86.00 - M86.9 Acute, chronic, or unspecified osteomyelitis [untreated osteomyelitis
within the vicinity of the wound]
T20.30x+ - Third degree burns face, head and neck [presence in the wound of
T20.39x+ necrotic tissue with eschar if debridement is not attempted]
T20.70x+ -
T20.79x+
T21.30x+ - Third degree burns trunk [presence in the wound of necrotic tissue with
T21.39x+ eschar if debridement is not attempted]
T21.70x+ -
T21.79x+
T22.30x+ - Third degree burns upper limb [presence in the wound of necrotic tissue
T22.399x+ with eschar if debridement is not attempted ]
T22.70x+ -
T22.799+
T23.301+ - Third degree burns wrist and hand [presence in the wound of necrotic
T23.399+ tissue with eschar if debridement is not attempted]
T23701+ -
T23.799+
T24.301+ - Third degree burns lower limb [presence in the wound of necrotic tissue
T24.399+ with eschar if debridement is not attempted]
T24.701+ -
T24.799+
T25.311+ -
T25.399+
T25.711+ -
T25.799+
T30.0 - T30.4 Burn and corrosion of unspecified body region [third degree burns]
T81.83x+ Persistent postoperative fistula [to an organ or body cavity within the
vicinity of the wound]
Page 55 of 68
The above policy is based on the following references:

1. Kalailieff D. Vacuum-assisted closure: Wound care technology for the new
millennium. Perspectives. 1998;22(3):28-29.
2. Hartnett JM. Use of vacuum-assisted wound closure in three chronic wounds.
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3. Voinchet V, Magalon G. Vacuum assisted closure. Wound healing by negative
pressure. Ann Chir Plast Esthet. 1996;41(5):583-589.
4. Blackburn JH 2d, Boemi L, Hall WW, et al. Negative-pressure dressings as a
bolster for skin grafts. Ann Plast Surg. 1998;40(5):453-457.
5. Argenta LC, Morykwas MJ. Vacuum-assisted closure: A new method for
wound control and treatment: Clinical experience. Ann Plast Surg. 1997;38
(6):563-577.
6. Mullner T, Mrkonjic L, Kwasny O, et al. The use of negative pressure to
promote the healing of tissue defects: A clinical trial using the vacuum sealing
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negative pressure therapy: A case report. Ostomy Wound Manage. 1999;45
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10. Deva AK, Siu C, Nettle WJ. Vacuum-assisted closure of a sacral pressure
sore. J Wound Care. 1997;6(7):311-312.
11. Deva AK, Buckland GH, Fisher E, et al. Topical negative pressure in wound
management. Med J Aust. 2000;173(3):128-131.
12. Avery C, Pereira J, Moody A, et al. Clinical experience with the negative
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13. Philbeck TE Jr, Whittington KT, Millsap MH, et al. The clinical and cost
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treatment of wounds in home healthcare Medicare patients. Ostomy Wound
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1998;18(1):27-29, 33-37.
17. Hopf HW, Humphrey LM, Puzziferri N, et al. Adjuncts to preparing wounds for
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18. Krasner DL. Managing wound pain in patients with vacuum-assisted closure
devices. Ostomy Wound Manage. 2002;48(5):38-43.
19. Ford CN, Reinhard ER, Yeh D, et al. Interim analysis of a prospective,
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wounds. Cochrane Database Syst Rev. 2001;(1):CD001898.
23. Wanner MB, Schwarzl F, Strub B, et al. Vacuum-assisted wound closure for
cheaper and more comfortable healing of pressure sores: A prospective
study. Scand J Plast Reconstr Surg Hand Surg. 2003;37(1):28-33.
24. Song DH, Wu LC, Lohman RF, et al. Vacuum assisted closure for the
treatment of sternal wounds: The bridge between debridement and definitive
closure. Plast Reconstr Surg. 2003;111(1):92-97.
25. Washington State Department of Labor and Industries, Office of the Medical
Director. Wound VAC. Coverage Decision. Olympia, WA: Washington State
Department of Labor and Industries; 2003.
26. Fisher A, Brady B. Vacuum assisted wound closure therapy. Ottawa, ON:
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27. Pham CT, Middleton P, Maddern G. Vacuum-assisted closure for the
management of wounds: An accelerated systematic review. ASERNIP-S
Report No. 37. Adelaide, SA: Australian Safety and Efficacy Register of New
Interventional Procedures – Surgical (ASERNIP-S); December 2003.
28. Kaplan M. Managing the open abdomen. Ostomy Wound Manage. 2004;50
(1A Suppl):C2, 1-8.
29. McGuinness JG, Winter DC, O'Connell PR. Vacuum-assisted closure of a
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30. Duxbury MS, Finlay IG, Butcher M, Lambert AW. Use of a vacuum assisted
closure device in pilonidal disease. J Wound Care. 2003;12(9):355.
31. Higgins S. The effectiveness of vacuum assisted closure (VAC) in wound
healing. Evidence Centre Evidence Report. Clayton, VIC: Centre for Clinical
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32. Lynch JB, Laing AJ, Regan PJ. Vacuum-assisted closure therapy: A new
treatment option for recurrent pilonidal sinus disease. Report of three cases.
Dis Colon Rectum. 2004;47(6):929-932.
33. Verrillo SC. Negative pressure therapy for infected sternal wounds: A literature
review. J Wound Ostomy Continence Nurs. 2004;31(2):72-74.
34. Armstrong DG, Attinger CE, Boulton AJ, et al. Guidelines regarding negative
wound therapy (NPWT) in the diabetic foot. Ostomy Wound Manage. 2004;50
(4B Suppl):3S-27S.
35. Kaplan M. Negative pressure wound therapy in the management of abdominal
compartment syndrome. Ostomy Wound Manage. 2004;50(11A Suppl):20S-
25S.
36. Gupta S, Baharestani M, Baranoski S, et al. Guidelines for managing pressure
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37. Samson D, Lefevre F, Aronson N. Wound-healing technologies: Low-level
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38. NHS Quality Improvement Scotland (NHS QIS). Vacuum assisted closure for
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39. Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat
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Literature Review. Toronto, ON: MAS; 2004.
40. Letter from Cynthia Hake, Director, Centers for Medicare and Medicaid
Services HCPCS Workgroup, Baltimore, MD, to Richard Weston, BlueSky
Medical Group, Inc., Vista, CA, regarding request to establish a code for
portable powered suction pump, trade name: Versitile Wound Vacuum
System, October 27, 2005.
41. Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative
pressure wound therapy after partial diabetic foot amputation: A multicentre,
randomised controlled trial. Lancet. 2005;366(9498):1704-1710.
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42. Costa V, Brophy J, McGregor M. Vacuum-assisted wound closure therapy

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43. Caniano DA, Ruth B, Teich S. Wound management with vacuum-assisted
closure: Experience in 51 pediatric patients. J Pediatr Surg. 2005;40(1):128-
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44. Gastelu-Iturri Bilbao J, Atienza Merino G. Vacuum-assisted closure
effectiveness for chronic wounds therapy. Technical Report [summary].
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45. Wasiak J, Cleland H. Topical negative pressure for partial thickness burns.
Cochrane Database Syst Rev. 2007;(3):CD006215.
46. Stannard JP, Robinson JT, Anderson ER, et al. Negative pressure wound
therapy to treat hematomas and surgical incisions following high-energy
trauma. J Trauma. 2006;60(6):1301-1306.
47. Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat
(MAS). Negative pressure wound therapy. Health Technology Literature
Review. Toronto, ON: MAS; 2006.
48. Institute for Quality and Efficiency in Health Care (IQWiG). Scientific
evaluation of the current status of medical knowledge on vacuum assisted
closure (VAC) therapy of wounds [summary]. Technology Assessment.
Cologne, Germany: IQWiG; 2006.
49. TriCenturion LLC. Negative pressure wound therapy (NPWT) widespread
probe results. Jurisdiction A – Final Report. Jurisdiction A/B DME PSC.
LPET20070219-E2402. Columbia, SC: Tricenturion; February 2007.
50. Vlayen J, Camberlin C, Ramaekers D. Negative pressure wound therapy: A
rapid assessment. KCE Reports 61. Brussels, Belgium: Belgian Health Care
Knowledge Centre (KCE); 2007.
51. Armstrong DG, Lavery LA, Boulton AJ. Negative pressure wound therapy via
vacuum-assisted closure following partial foot amputation: What is the role of
wound chronicity? Int Wound J. 2007;4(1):79-86.
52. Schimmer C, Sommer SP, Bensch M, Leyh R. Primary treatment of deep
sternal wound infection after cardiac surgery: A survey of German heart
surgery centers. Interact Cardiovasc Thorac Surg. 2007;6(6):708-711.
53. Morris GS, Brueilly KE, Hanzelka H. Negative pressure wound therapy
achieved by vacuum-assisted closure: Evaluating the assumptions. Ostomy
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Page 59 of 68
54. Gregor S, Maegele M, Sauerland S, et al. Negative pressure wound therapy:

A vacuum of evidence? Arch Surg. 2008;143(2):189-196.
55. Blume PA, Walters J, Payne W, et al. Comparison of negative pressure wound
therapy using vacuum-assisted closure with advanced moist wound therapy in
the treatment of diabetic foot ulcers: A multicenter randomized controlled trial.
Diabetes Care. 2008;31(4):631-636.
56. Ubbink DT, Westerbos SJ, Evans D, et al. Topical negative pressure for
treating chronic wounds. Cochrane Database Syst Rev. 2008;(3):CD001898.
57. Vikatmaa P, Juutilainen V, Kuukasjärvi P, et al. Negative pressure wound
therapy: A systematic review on effectiveness and safety. Eur J Vasc
Endovasc Surg. 2008;36(4):438-448.
58. Bee TK, Croce MA, Magnotti LJ, et al. Temporary abdominal closure
techniques: A prospective randomized trial comparing polyglactin 910 mesh
and vacuum-assisted closure. J Trauma. 2008;65(2):337-342.
59. Expert Working Group. Vacuum assisted closure: Recommendations for use.
A consensus document. Int Wound J. 2008;5 Suppl 4:iii-19.
60. Bovill E, Banwell PE, Teot L, et al; International Advisory Panel on Topical
Negative Pressure. Topical negative pressure wound therapy: A review of its
role and guidelines for its use in the management of acute wounds. Int Wound
J. 2008;5(4):511-529.
61. Sumpio BE, Allie DE, Horvath KA, et al. Role of negative pressure wound
therapy in treating peripheral vascular graft infections. Vascular. 2008;16
(4):194-200.
62. Baharestani MM, Houliston-Otto DB, Barnes S. Early versus late initiation of
negative pressure wound therapy: Examining the impact on home care length
of stay. Ostomy Wound Manage. 2008;54(11):48-53.
63. Baharestani MM, Driver VR, de Leon JM, et al. Optimizing clinical and cost
effectiveness with early intervention of v.a.c.(R) therapy. Ostomy Wound
Manage. 2008;54(11):1-15.
64. Sadat U, Chang G, Noorani A, et al. Efficacy of TNP on lower limb wounds: A
meta-analysis. J Wound Care. 2008;17(1):45-48.
65. Sullivan N, Snyder DL, Tipton K, et al. Negative pressure wound therapy
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(AHRQ), Contract No. 290-2007-10063. Project ID: WNDT1108. Rockville,
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66. Gregor S, Maegele M, Sauerland S, et al. Negative pressure wound
therapy: A vacuum of evidence? Arch Surg. 2008;143(2):189-196.
Page 60 of 68
67. Ubbink DT, Vermeulen H, Segers P, Goslings JC. Negative pressure therapy
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68. Open Abdomen Advisory Panel, Campbell A, Chang M, Fabian T, et al.
Management of the open abdomen: From initial operation to definitive closure.
Am Surg. 2009;75(11 Suppl):S1-S22.
69. National Institute for Health and Clinical Excellence (NICE). Negative pressure
wound therapy for the open abdomen. Interventional Procedure Guidance
322. London, UK: NICE; December 2009.
70. Ritchie K, Abbotts J, Downie S, et al. Topical negative pressure therapy for
wounds. HTA Report 12. Glasgow, Scotland: Quality Improvement Scotland
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71. Pliakos I, Papavramidis TS, Mihalopoulos N, et al. Vacuum-assisted closure in
severe abdominal sepsis with or without retention sutured sequential fascial
closure: A clinical trial. Surgery. 2010;148(5):947-953.
72. Scimeca CL, Bharara M, Fisher TK, et al. Novel use of insulin in continuous-
instillation negative pressure wound therapy as "wound chemotherapy". J
Diabetes Sci Technol. 2010a;4(4):820-824.
73. Scimeca CL, Bharara M, Fisher TK, et al. Novel use of doxycycline in
continuous-instillation negative pressure wound therapy as "wound
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74. Xie X, McGregor M. Negative Pressure wound therapy (NPWT). Update to
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75. Xie X, McGregor M, Dendukuri N. The clinical effectiveness of negative
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76. Health Technology Inquiry Service (HTIS). Negative pressure therapy for
patients infected wounds: A review of the clinical and cost-effectiveness
evidence and recommendations for use. Ottawa, ON: Canadian Agency for
Drugs and Technologies in Health (CADTH): July 14, 2010.
77. Ontario Ministry of Health and Long-term Care, Medical Advisory Secretariat
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78. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory
Panel. Pressure ulcer treatment recommendations. In: Prevention and
treatment of pressure ulcers: Clinical practice guideline. Washington, DC:
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Page 61 of 68
79. U.S. Food and Drug Administration. Medical devices; general and plastic
surgery devices; classification of non-powered suction apparatus device
intended for negative pressure wound therapy. Final rule. Fed Regist. 2010;75
(221):70112-70114.
80. Suissa D, Danino A, Nikolis A. Negative-pressure therapy versus standard
wound care: A meta-analysis of randomized trials. Plast Reconstr Surg.
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81. Vig S, Dowsett C, Berg L, et al; International Expert Panel on Negative
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the use of negative pressure wound therapy in chronic wounds: Steps towards
an international consensus. J Tissue Viability. 2011;20 Suppl 1:S1-S18.
82. ECRI Institute. FDA warns of bleeding, infection related to negative-pressure
wound therapy. Health Technology Trends. 2011;23(6):4-5, 8.
83. Webster J, Scuffham P, Sherriff KL, et al. Negative pressure wound therapy
for skin grafts and surgical wounds healing by primary intention. Cochrane
Database Syst Rev. 2012;(4):CD009261.
84. Roberts DJ, Zygun DA, Grendar J, et al. Negative-pressure wound therapy for
critically ill adults with open abdominal wounds: A systematic review. J
Trauma Acute Care Surg. 2012;73(3):629-639.
85. Dumville JC, Munson C. Negative pressure wound therapy for partial-
thickness burns. Cochrane Database Syst Rev. 2012;(12):CD006215.
86. Fraccalvieri M, Sarno A, Gasperini S, et al. Can single use negative pressure
wound therapy' be an alternative method to manage keloid scarring? A
preliminary report of a clinical and ultrasound/colour-power-doppler study. Int
Wound J. 2013;10(3):340-344.
87. van den Bulck R, Siebers Y, Zimmer R, et al. Initial clinical experiences with a
new, portable, single-use negative pressure wound therapy device. Int Wound
J. 2013;10(2):145-151.
88. Gabriel A, Thimmappa B, Rubano C, Storm-Dickerson T. Evaluation of an
ultra-lightweight, single-patient-use negative pressure wound therapy system
over dermal regeneration template and skin grafts. Int Wound J. 2013;10
(4):418-424.
89. Dowsett C, Grothier L, Henderson V, et al. Venous leg ulcer management:
Single use negative pressure wound therapy. Br J Community Nurs.
2013;Suppl:S6, S8-10, S12-S15.
90. Sharp E. Single-use NPWT for the treatment of complex orthopaedic surgical
and trauma wounds. J Wound Care. 2013;22(10 Suppl):S5-S9.
Page 62 of 68
91. National Institute for Health and Clinical Excellence (NICE). Negative pressure
wound therapy for the open abdomen. Interventional Procedure Guidance
467. London, UK: NICE; November 2013.
92. Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparison of
negative pressure wound therapy with an ultraportable mechanically powered
device vs. traditional electrically powered device for the treatment of chronic
lower extremity ulcers: A multicenter randomized-controlled trial. Wound
Repair Regen. 2011;19(2):173-180.
93. Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparative
effectiveness of mechanically and electrically powered negative pressure
wound therapy devices: A multicenter randomized controlled trial. Wound
Repair Regen. 2012;20(3):332-341.
94. Bendewald FP, Cima RR, Metcalf DR, Hassan I. Using negative pressure
wound therapy following surgery for complex pilonidal disease: A case series.
Ostomy Wound Manage. 2007;53(5):40-46.
95. Farrell D, Murphy S. Negative pressure wound therapy for recurrent pilonidal
disease: A review of the literature. J Wound Ostomy Continence Nurs.
2011;38(4):373-378.
96. Ousey KJ, Atkinson RA, Williamson JB, Lui S. Negative pressure wound
therapy (NPWT) for spinal wounds: A systematic review. Spine J. 2013;13
(10):1393-1405.
97. Mark KS, Alger L, Terplan M. Incisional negative pressure therapy to prevent
wound complications following Cesarean section in morbidly obese women: A
pilot study. Surg Innov. 2013;21(4):345-349.
98. Karlakki S, Brem M, Giannini S, et al. Negative pressure wound therapy for
management of the surgical incision in orthopaedic surgery: A review of
evidence and mechanisms for an emerging indication. Bone Joint Res. 2013;2
(12):276-284.
99. Selvaggi F, Pellino G, Sciaudone G, et al. New advances in negative pressure
wound therapy (NPWT) for surgical wounds of patients affected with Crohn's
disease. Surg Technol Int. 2014;24:83-89.
100. Webster J, Scuffham P, Stankiewicz M, Chaboyer WP. Negative pressure
wound therapy for skin grafts and surgical wounds healing by primary
intention. Cochrane Database Syst Rev. 2014;10:CD009261.
101. Dumville JC, Munson C, Christie J. Negative pressure wound therapy for
partial-thickness burns. Cochrane Database Syst Rev. 2014;12:CD006215.
Page 63 of 68
102. Kostaras EK, Tansarli GS, Falagas ME. Use of negative-pressure wound
therapy in breast tissues: Evaluation of the literature. Surg Infect (Larchmt).
2014;15(6):679-685.
103. Schlatterer DR, Hirschfeld AG, Webb LX. Negative pressure wound therapy in
grade IIIB tibial fractures: Fewer infections and fewer flap procedures? Clin
Orthop Relat Res. 2015;473(5):1802-1811.
104. Echebiri NC, McDoom MM, Aalto MM, et al. Prophylactic use of negative
pressure wound therapy after cesarean delivery. Obstet Gynecol. 2015;125
(2):299-307.
105. Rouse DJ. Prophylactic negative pressure wound therapy: We need proof
before application. Obstet Gynecol. 2015;125(2):297-298.
106. Rhee SM, Valle MF, Wilson LM, et al. Negative pressure wound therapy
technologies for chronic wound care in the home setting. Evidence
Report/Technology Assessment. Prepared by the Johns Hopkins University
Evidence-based Practice Center under Contract No. 290-201-200007-I.
Rockville, MD: Agency for Healthcare Research and Quality; August 2014.
107. Rhee SM, Valle MF, Wilson LM, et al. Negative pressure wound therapy
technologies for chronic wound Care in the home setting. Evidence
Report/Technology Assessment. (Prepared by the Johns Hopkins University
Evidence-based Practice Center under Contract No. 290-201-200007-I).
Rockville, MD: Agency for Healthcare Research and Quality. August 2014.
108. Soares KC, Baltodano PA, Hicks CW, et al. Novel wound management
system reduction of surgical site morbidity after ventral hernia repairs: A
critical analysis. Am J Surg. 2015;209(2):324-332.
109. Rodriguez-Unda N, Soares KC, Azoury SC, et al. Negative-pressure wound
therapy in the management of high-grade ventral hernia repairs. J
Gastrointest Surg. 2015;19(11):2054-2061.
110. Dale AP, Saeed K. Novel negative pressure wound therapy with instillation
and the management of diabetic foot infections. Curr Opin Infect Dis. 2015;28
(2):151-157.
111. Kim PJ, Attinger CE, Steinberg JS, Evans KK. Negative pressure wound
therapy with instillation: Past, present, and future. Surg Technol Int.
2015;26:51-56.
112. Gupta S, Gabriel A, Lantis J, Teot L. Clinical recommendations and practical
guide for negative pressure wound therapy with instillation. Int Wound J.
2016;13(2):159-174.
Page 64 of 68
113. Santarpino G, Gazdag L, Sirch J, et al. A retrospective study to evaluate use

of negative pressure wound therapy in patients undergoing bilateral internal
thoracic artery grafting. Ostomy Wound Manage. 2015;61(12):26-30.
114. Manoharan V, Grant AL, Harris AC, et al. Closed incision negative pressure
wound therapy vs conventional dry dressings after primary knee arthroplasty:
A randomized controlled study. J Arthroplasty. 2016;31(11):2487-2494.
115. Fischer S, Wall J, Pomahac B, et al. Extra-large negative pressure wound
therapy dressings for burns - Initial experience with technique, fluid
management, and outcomes. Burns. 2016;42(2):457-465.
116. Kantak NA, Mistry R, Halvorson EG. A review of negative-pressure wound
therapy in the management of burn wounds. Burns. 2016;42(8):1623-1633.
117. Shrestha BM. Systematic review of the negative pressure wound therapy in
kidney transplant recipients. World J Transplant. 2016;6(4):767-773.
118. Shen P, Blackham A, Lewis S, et al. Phase II randomized trial of negative
pressure wound therapy to decrease surgical site infection in patients
undergoing laparotomy for gastrointestinal, pancreatic, and peritoneal surface
malignancies. J Am Coll Surg. 2017;224(4):726-737.
119. Dingemans SA, Birnie MFN, Backes M, et al. Prophylactic negative pressure
wound therapy after lower extremity fracture surgery: A pilot study. Int
Orthop. 2018;42(4):747-753.
120. Gatti G, Ledwon M, Gazdag L, et al. Management of closed sternal incision
after bilateral internal thoracic artery grafting with a single-use negative
pressure system. Updates Surg. 2018;70(4):545-552.
121. Tanaydin V, Beugels J, Andriessen A, et al. Randomized controlled study
comparing disposable negative-pressure wound therapy with standard
care in bilateral breast reduction mammoplasty evaluating surgical site
complications and scar quality. Aesthetic Plast Surg. 2018;42(4):927-935.
122. Pellino G, Sciaudone G, Candilio G, et al. Preventive NPWT over closed
incisions in general surgery: Does age matter? Int J Surg. 2014;12(Suppl
2):S64-S68.
Payne C, Edwards D. Application of the single use negative pressure
wound therapy device (PICO) on a heterogeneous group of surgical and
traumatic wounds. Eplasty. 2014;14:e20.
123. Adogwa O, Fatemi P, Perez E, et al. Negative pressure wound therapy
reduces incidence of postoperative wound infection and dehiscence after
long-segment thoracolumbar spinal fusion: A single institutional
experience. Spine J. 2014;14(12):2911-2917.
Page 65 of 68
124. Chaboyer W, Anderson V, Webster J, et al. Negative pressure wound

therapy on surgical site infections in women undergoing elective
Caesarean sections: A pilot RCT. Healthcare (Basel). 2014;2(4):417-428.
125. Gillespie BM, Rickard CM, Thalib L, et al. Use of negative-pressure wound
dressings to prevent surgical site complications after primary hip
arthroplasty: A pilot RCT. Surg Innov. 2015;22(5):488-495.
126. Holt R, Murphy J. PICO™ incision closure in oncoplastic breast surgery: A
case series. Br J Hosp Med (Lond). 2015;76(4):217-223.
127. Matsumoto T, Parekh SG. Use of negative pressure wound therapy on
closed surgical incision after total ankle arthroplasty. Foot Ankle Int.
2015;36(7):787-794.
128. Witt-Majchrzak A, Zelazny P, Snarska J. Preliminary outcome of treatment
of postoperative primarily closed sternotomy wounds treated using
negative pressure wound therapy. Pol Przegl Chir. 2015;86(10):456-465.
129. Hampton J. Providing cost-effective treatment of hard-to-heal wounds in
the community through use of NPWT. Br J Community Nurs. 2015;Suppl
Community Wound Care:S14, S16-S20.
130. Nordmeyer M, Pauser J, Biber R, et al. Negative pressure wound therapy
for seroma prevention and surgical incision treatment in spinal fracture
care. Int Wound J. 2016;13(6):1176-1179.
131. Hyldig N, Birke-Sorensen H, Kruse M, et al. Meta-analysis of negative-
pressure wound therapy for closed surgical incisions. Br J Surg. 2016;103
(5):477-486.
132. Karlakki SL, Hamad AK, Whittall C, et al. Incisional negative pressure
wound therapy dressings (iNPWTd) in routine primary hip and knee
arthroplasties: A randomised controlled trial. Bone Joint Res. 2016;5
(8):328-337.
133. Uchino M, Hirose K, Bando T, et al. Randomized controlled trial of
prophylactic negative-pressure wound therapy at ostomy closure for the
prevention of delayed wound healing and surgical site infection in patients
with ulcerative colitis. Dig Surg. 2016;33(6):449-454.
134. O'Leary DP, Peirce C, Anglim B, et al. Prophylactic negative pressure
dressing use in closed laparotomy wounds following abdominal
operations: A randomized, controlled, open-label trial: The P.I.C.O. Trial.
Ann Surg. 2017;265(6):1082-1086.
135. Strugala V, Martin R. Meta-analysis of comparative trials evaluating a
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(7):810-819.
136. Gupta R, Darby GC, Imagawa DK. Efficacy of negative pressure wound
treatment in preventing surgical site infections after Whipple procedures.
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137. Delhougne G, Hogan C, Tarka K, Nair S. A retrospective, cost-minimization
analysis of disposable and traditional negative pressure wound therapy
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138. Fleming CA, Kuteva M, O'Hanlon K, et al. Routine use of PICO dressings
may reduce overall groin wound complication rates following peripheral
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139. Galiano RD, Hudson D, Shin J, et al. Incisional negative pressure wound
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Page 68 of 68
Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan
benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,
general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care
services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in
private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible
for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to
change.
Copyright © 2001-2019 Aetna Inc.
AETNA BETTER HEALTH® OF PENNSYLVANIA
Amendment to
Aetna Clinical Policy Bulletin Number: 0334 Negative
Pressure Wound Therapy
There are no amendments for Medicaid.
www.aetnabetterhealth.com/pennsylvania revised 05/24/2019

0334 Negative Pressure Wound Therapy

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Page 1 of 68

Negative Pressure Wound

Clinical Policy Bulletins Medical Clinical Policy Bulletins

Aetna considers negative pressure wound therapy (NPWT) pumps medically

I. Ulcers and Wounds in the Home Setting Next Review: 03/27/2020

 Application of dressings to maintain a moist wound environment, and

 Debridement of necrotic tissue if present, and

B. For Stage III or IV pressure ulcers:

 The member has been appropriately turned and positioned, and

 The member's moisture and incontinence have been appropriately

C. For neuropathic (e.g., diabetic) ulcers:

 The member has been on a comprehensive diabetic management

D. For venous insufficiency ulcers:

 Compression bandages and/or garments have been consistently applied,

II. Ulcers and Wounds Encountered in an Inpatient Setting

A. An ulcer or wound (described in section I above) is encountered in the

B. The member has complications of a surgically created wound (e.g.,

C. Management of fasciotomy wounds in persons with compartment

Note: NPWT pumps must be capable of accommodating more than 1

A. The presence in the wound of necrotic tissue with eschar, if debridement

IV. Continued Medical Necessity

B. On at least a monthly basis, document changes in the ulcer's dimensions

E. When criteria under section on Continued Medical Necessity above,

A. Up to a maximum of 15 dressing kits per wound per month is considered

B. Up to a maximum of 10 canister sets per month is considered medically

See specifications of equipment and supplies in the Appendix.

Note: Staging of pressure ulcers used in this policy is as follows:

Table: Stages of pressure ulcers

List of stages Description

boggy, warmer or cooler as compared to adjacent tissue.

color may differ from the surrounding area.

or pink wound bed, without slough. May also present as an intact or

open/ruptured serum-filled blister.

obscure the depth of tissue loss. May include undermining or tunneling.

undermining and tunneling.

black) in the wound bed.

See also CPB 0244 - Wound Care) (../200_299/0244.html).

Negative pressure wound therapy is the controlled application of subatmospheric

More than a dozen systematic evidence reviews produced by independent

Control of intra-abdominal fluid secretion, facilitation of abdominal exploration, and

injuries, and severe intra-abdominal sepsis. In a review on the management of

Morris et al (2007) noted that although NPWT appears effective, it remains

can be drawn regarding the relative effectiveness of vacuum-assisted wound

Gregor et al (2008) examined the clinical effectiveness and safety of negative

Vikatmaa et al (2008) conducted a systematic review of the literature on the safety

clinical evidence supporting the advantages of NPWT compared to other

More recently, the Johns Hopkins University Evidence-based Practice Center

Negative pressure wound therapy uses a reticulated sponge and subatmospheric

wound chemo-therapeutic agents such as insulin, which acts as a growth factor,

A non-powered (mechanical) NPWT device, the Smart Negative Pressure (SNaP)

Armstrong et al (2012) compared the portable mechanically powered Smart

The European Pressure Ulcer Advisory Panel's clinical practice guideline on

In a systematic review, Roberts et al (2012) determined the comparative safety and

In a Cochrane review, Dumville and Munson (2012) evaluated the effectiveness of

Fraccalvieri et al (2013) stated that keloid scarring represents a pathological

Bendewald et al (2007) stated that complex pilonidal disease, an uncommon

risk of recurrent pilonidal disease or wound failure following negative pressure

Ousey et al (2013) stated that the management of post-operative spinal wound

presence of active cerebrospinal fluid leak, metastatic or neoplastic disease in the

Karlakki et al (2013) stated that the period of post-operative treatment before

In a Cochrane review, Webster et al (2014) evaluated the effects of NPWT on

wounds); seroma/hematoma; or failed skin grafts. Lower re-operation rates were

Infections (including necrotizing fasciitis), pyoderma gangrenosum, and necrosis

In a pilot study, Mark et al (2013) assessed the effectiveness of incisional negative