From the Society for Vascular Surgery

A randomized clinical trial evaluating negative pressure

therapy to decrease vascular groin incision
complications
Jeontaik Kwon, MD, Cara Staley, CRNP, Megan McCullough, CRNP, Selena Goss, MD,
Mariano Arosemena, MD, Babak Abai, MD, Dawn Salvatore, MD, David Reiter, MD, and Paul DiMuzio, MD,
Philadelphia, Pa

ABSTRACT
Objective: Vascular groin incision complications contribute significantly to patients’ morbidity and rising health care
costs. Negative pressure therapy over the closed incision decreases the infection rate in cardiac and orthopedic pro-
cedures. This study prospectively evaluated negative pressure therapy as a means to decrease wound complications and
associated health care costs.
Methods: This was a randomized, prospective, single-institution study of 119 femoral incisions closed primarily after
elective vascular surgery including both inflow (eg, aortofemoral) and outflow (eg, femoral-popliteal bypass) procedures.
Incisions were categorized as high risk for wound complications on the basis of body mass index >30 kg/m2, pannus,
reoperation, prosthetic graft, poor nutrition, immunosuppression, or hemoglobin A1c >8% and randomized 1:1 to standard
gauze (n ¼ 60) dressing vs negative pressure therapy (Prevena [Acelity, San Antonio, Tex], n ¼ 59). Wound complication
rate, length of stay (LOS), reoperation, readmission, and variable hospital costs were determined during 30 days. Statistical
analysis was performed using c2 test along with a two-sample unpaired t-test for continuous variables.
Results: There were no significant demographic differences (age, sex, risk factors for wound complication) between the
two high-risk groups. In low-risk controls, the major wound complication rate was 4.8% (involving one infection in 21
incisions), resulting in a 3.8-day LOS, 4.8% reoperation, 4.8% readmission rate, and $17,599 in average variable cost. For
high-risk controls, there was a significant increase in major wound complications to 25% (including all 12 infections in 60
incisions), LOS (10.6 days), reoperation (18.3%), readmission (16.7%), and costs ($36,537). Finally, negative pressure therapy
significantly reduced major wound complications to 8.5% (including five of six infections in 59 incisions; P < .001),
reoperation (8.5%; P < .05), and readmission (6.8%; P < .04) but not LOS (10.6 days). The average variable cost was reduced
($30,492), yielding an average savings of $6045 per patient (P ¼ .11).
Conclusions: This study suggests that negative pressure therapy significantly reduces the major wound complication,
reoperation, and readmission rates for patients at high risk for groin wound complications. Furthermore, this therapy may
lead to a reduction in hospital costs. Negative pressure therapy for all groin incisions considered at high risk for wound
complications is recommended. (J Vasc Surg 2018;68:1744-52.)
Keywords: Negative pressure therapy; Vascular groin incision complications; Wound infection

The incidence of surgical site complications after infrain-
guinal vascular surgery ranges from 17% to 44%.1-5 Risk fac-
tors for these complications have been well documented
and include obesity, reoperation, emergent surgery, use of
From the Division of Vascular and Endovascular Surgery, Thomas Jefferson Uni-
versity Hospital.
Clinical Trial registration: NCT02581904.
Author conflict of interest: none.
Presented at the 2017 Vascular Annual Meeting of the Society for Vascular Sur-
gery, San Diego, Calif, May 31-June 3, 2017.
Correspondence: Paul DiMuzio, MD, 111 S 11th St, Ste G6210, Philadelphia, PA
19107 (e-mail: paul.dimuzio@jefferson.edu).
The editors and reviewers of this article have no relevant financial relationships to
disclose per the JVS policy that requires reviewers to decline review of any
manuscript for which they may have a conflict of interest.
0741-5214
Copyright Ó 2018 by the Society for Vascular Surgery. Published by Elsevier Inc.
https://doi.org/10.1016/j.jvs.2018.05.224
prosthetic graft, diabetes mellitus, renal failure, and poor
nutrition.3,5-12 The proximity of the surgical site to the peri-
neum and lymphatic disturbance are thought to
contribute to the risk of infection.4
The consequences of surgical site complications can be
devastating, including failure of vascular intervention,
sepsis, limb loss, and mortality.7,13-18 Furthermore, surgical
site complications result in significant economic burden
in terms of increased length of stay (LOS), readmissions,
reoperations, and overall health care costs.16,19-29 For
example, studies have demonstrated significant
increases in LOS and hospital costs (an additional
4.3 days and $10,497, respectively, to the index admission)
directly attributable to surgical site infection.30,31
Various closure and wound management techniques
have shown limited benefit in terms of reducing
morbidity and costs with regard to vascular groin inci-
sions.3,10,32-35 Several studies in cardiac and orthopedic

1744
Journal of Vascular Surgery
Volume 68, Number 6
surgery demonstrated significant reductions in wound
complications in high-risk populations by applying a
negative pressure dressing over the primarily closed
incision (Prevena Incision Management System; Acelity,
San Antonio, Tex).36-38 A recent meta-analysis of 10
studies (1089 patients, 1311 incisions) assessing negative
pressure therapy suggested this as an effective strategy
for reducing seroma formation and infections.39 Studies
specifically addressing vascular groin incisions, however,
have been inconclusive. Matatov et al40 demonstrated a
significant decrease in groin wound infection after
vascular surgery with application of negative pressure
therapy, a finding not confirmed in a similar retrospec-
tive study by Koetje et al.41 Lee et al42 recently published
a prospective, randomized trial suggesting a decrease in
vascular groin wound infection rate in a high-risk popu-
lation, but this did not achieve statistical significance.
A prospective, randomized, single-center study was
designed to evaluate the effect of negative pressure
therapy on the healing of elective vascular surgery
groin incisions compared with standard dressings dur-
ing a 30-day period. The primary end point was major
wound complication rate; the secondary end points
were LOS, reoperation, readmission, and variable hospi-
tal costs. We hypothesized that the application of
negative pressure therapy would not decrease the
groin wound complication rate or any associated
health care costs.
METHODS
This study was approved by the Institutional Review
Board of Thomas Jefferson University (Control #14D.595)
and reported using the Consolidated Standards of Report-
ing Trials 2010 guidelines (www.consort-statement.org). It
was performed without any support, financial or otherwise,
from the makers of the Prevena dressing.
Trial design. This was a randomized, prospective,
single-center clinical trial designed to determine
whether application of a negative pressure dressing
(Prevena Incision Management System) is superior to a
standard surgical dressing in preventing vascular groin
wound complications and their associated hospital costs.
Participants. All patients aged 18 years and older
undergoing elective vascular surgery under the supervi-
sion of the Division of Vascular and Endovascular Surgery
at Thomas Jefferson University Hospital involving unilat-
eral or bilateral groin incisions were offered enrollment
in the study. The surgical procedures (Table I) included
inflow and outflow vascular bypass configurations (eg,
aortofemoral bypass and femoral-distal bypass, respec-
tively) as well as cutdown for vascular access (eg, endo-
vascular aneurysm repair). Exclusion criteria included
emergency operation and those unwilling or unable to
provide informed consent.
Kwon et al 1745
ARTICLE HIGHLIGHTS
d
Type of Research: Single-center, randomized
controlled trial
d
Take Home Message: A randomized controlled trial
was performed for 119 high-risk femoral incisions,
and negative pressure therapy resulted in fewer
wound infections (8.5% vs 25%) and fewer readmis-
sions (6.8% vs 16.7%) compared with standard gauze
dressings.
d
Recommendation: This study recommends that
negative pressure wound therapy be used in high-
risk femoral incisions.
Interventions. At the conclusion of the procedure, the
surgical wounds were closed in layers of Vicryl suture,
followed by skin closure with either staples or running
Monocryl subcuticular suture at the discretion of the
attending surgeon (P.D., D.S., B.A.).
While in the operating room, the patient was deter-
mined to be at either low or high risk for the develop-
ment of groin wound complications by the nurse
practitioners (C.S., M.M.). High risk was determined by
the presence of any of the following criteria: body mass
index (BMI) >30 kg/m2; significant pannus overlying
groin skin or abnormal skin as evidenced by fungal infec-
tion; reoperative groin surgery; placement of prosthetic
vascular graft; poor nutrition (BMI <18 kg/m2, cachectic
in appearance); immunosuppression (use of any immu-
nosuppressive medications); and poorly controlled
diabetes (hemoglobin A1c >8%).
Those not meeting any of these criteria were consid-
ered to be at low risk and subsequently received a stan-
dard surgical dressing consisting of gauze covered by
Tegaderm (3M, St. Paul, Minn). This dressing was
removed on postoperative day 2 and replaced with a
dry gauze dressing that was inspected and replaced
daily until discharge. This group defined the low-risk
controls.
Those meeting any of the criteria were considered to be
at high risk and randomized to receive either the standard
surgical dressing as described (high-risk controls) or the
negative pressure dressing (Prevena) applied according
to the manufacturer’s instructions (high-risk Prevena
group). Briefly, this dressing involved application of an
antibiotic sponge (0.019% ionic silver), cut to cover the
closed groin wound, covered by a clear occlusive dressing
attached to a suction device that applied 125 mm Hg
pressure. This device was inspected daily and left in place
for 5 days, after which a dry gauze dressing was placed,
inspected and replaced daily until discharge.
Outcomes. The primary end point was major groin
wound complication rate at 30 days. Complications
included skin dehiscence, lymph leakage (seroma or
1746 Kwon et al
Table I. Procedures performed in high-risk groups
High risk,
standard High risk,
dressing Prevena
Procedure (n ¼ 60) (n ¼ 59)
Access (EVAR) 5 9
Inflow procedures
Aortofemoral bypass 14 14
Axillary-femoral bypass 5 5
Femoral-femoral bypass 6 6
Femoral endarterectomy, 18 16
thrombectomy, repair
Outflow procedures
Femoral-distal bypass (venous 8 4
conduit)
Femoral-distal bypass (prosthetic 4 5
conduit)
EVAR, Endovascular aneurysm repair.
All incisions were vertical except those performed for access (EVAR),
which were all oblique.
fistula), infection (superficial or deep, as defined by the
Szilagyi classification),43 and hematoma. A major
complication was defined as any wound complication
requiring intravenous antibiotics, reoperation, or hospital
readmission. Wound assessment was made by both the
primary surgeon and nurse practitioners, as follows: daily
until hospital discharge; within 10 to 14 days, whereupon
staples were removed; and within 25 to 30 days to
complete the study. Wound infection was treated with
intravenous antibiotics and opened up surgically at the
discretion of the attending surgeon. Wound culture
specimens were obtained in the operating room, but no
attempt was made to quantify the specimens.
The secondary end points were LOS (index LOS was
defined as operation to discharge; 30-day LOS was
defined as the index LOS plus all readmission days within
30 days related to any wound complication); reoperation
for groin wound complication within 30 days (this
involved incision and drainage in the operating room;
opening the skin to drain a superficial soft tissue infec-
tion at the bedside or in the office was not considered
reoperation); readmission for groin wound complication
within 30 days; and variable hospital costs (for both the
index hospitalization and all readmission days within
30 days related to any wound complication). Hospital
variable costs (not charges) for each admission were
obtained from hospital administration.
Bilateral procedures. In the case of bilateral proced-
ures, the patient received standard dressing on one
side and negative pressure on the other. Both wounds
were evaluated independently in terms of wound
complications, return to the operating room, and read-
mission. Because a contralateral complication would
Journal of Vascular Surgery
December 2018
penalize the uncomplicated groin incision in terms of
LOS and hospital variable costs, in this circumstance
the uncomplicated groin incision data were dropped
from consideration in terms of LOS and variable costs.
As such, for the high-risk, standard dressing group
(n ¼ 60), five were dropped because of a contralateral
complication (n ¼ 55); for the high-risk, Prevena group
(n ¼ 59), eight were dropped because of a contralateral
complication (n ¼ 51).
Sample size. Before our study, a retrospective analysis
(unpublished) of the most recent 28 groin incisions per-
formed by the Division of Vascular and Endovascular Sur-
gery at Thomas Jefferson University Hospital revealed no
wound complications in three patients considered low
risk vs eight complications in 25 patients considered
high risk for wound complications (32%). This is consis-
tent with the general literature and was therefore
accepted as the baseline metric for this study.40 The
projected reduction in this rate from use of the investi-
gational device was set at 50%, a conservative goal in
view of the anecdotally observed and formally reported
effect of the device in clinical use to date.
To show that an observed reduction in wound infection
rate from 30% to 15% is statistically significant (power of
0.80 and type I error of .05), the required sample size for
a two-group comparison of effect size is 150 (75 in each
group) per DSS Researcher’s Toolkit44 and UCSF online
sample size calculator.45 A randomized trial of consecu-
tive patients was thus carried out with the intent to
accrue 150 high-risk incisions.
Stopping guidelines. Retrospective analysis suggested
that negative pressure therapy reduces wound compli-
cations by 50%.40 The Prevena device at Thomas Jeffer-
son University Hospital costs $500. We elected to
evaluate our results 80% of the way through the trial (120
high-risk groin incisions). The trial would be stopped if in
patients at high risk for wound complication negative
pressure therapy resulted in a >50% reduction in wound
complications (P < .001) while hospital variable costs
were less than or equal to standard dressing or negative
pressure therapy resulted in <5% reduction in wound
complications while hospital variable costs were greater
than or equal to standard dressing.
Randomization. After informed consent, while the
patient was in the operating room and after wound
closure, the nurse practitioners determined whether
the patient met the criteria for high risk. If the patient
was deemed to be at high risk, they used a coin toss to
determine whether the patient was to receive standard
dressing or negative pressure therapy. To maintain 1:1
randomization as well as to provide future analysis using
internal controls, any high-risk patient undergoing
bilateral groin incisions would receive both a standard
dressing and negative pressure therapy.
Journal of Vascular Surgery
Volume 68, Number 6
Assessed for eligibility
Enrollment
Excluded from randomization (n=24 incisions)
♦“Low risk” for complicaons (n=21 incisions)
♦Declined to participate (n=3 incisions)
Randomized “high risk” (n=123 incisions)
Allocated to standard dressing (n=62 incisions)
♦ Received allocated intervention (n=62 incisions)
Lost to follow-up (n=0)
Discontinued intervention (re-opening of
incision for graft failure post-operative Day 1;
fatal myocardial infarction post-operative Day
3) (n=2)
Analysed (n=60 incisions) “high-risk, standard
dressing”
Received standard dressing and
Analysed (n=21 incisions) “low-risk, standard
dressing”
Fig. Flow diagram of 147 groin incisions made in 122 patients considered for enrollment into the study. A total of
25 patients underwent bilateral procedures, 1 in the low-risk control group and 24 in the high-risk groups.
Blinding. Other than the fact that the 30-day exami-
nation occurred without the overt knowledge of the
patient’s initial treatment, no blinding was instituted.
Statistical methods. The significances of differences in
proportion among groups were determined with the
N  1 variant of Pearson c2 test using the MedCalc online
calculator (MedCalc Software, Ostend, Belgium). This
approach was chosen over the unmodified test because
cohorts are relatively small. For continuous variables
(age, cost, LOS), a two-sample unpaired t-test was
performed. Numerical values are reported as mean 6
standard deviation. Statistical significance was defined
as a P < .05.
RESULTS
Treatment groups. The Fig reveals the fate of 147
incisions made in 122 patients considered for enrollment
in the study between January 1, 2015, and December 31,
2016. Of the 123 incisions deemed high risk for
Kwon et al 1747
(n=147 incisions
In 122 patients)
Allocation
Allocated to Prevena dressing (n=61 incisions)
♦ Received allocated intervention (n=61 incisions)
Follow-Up
Lost to follow-up (n=0)
Discontinued intervention (re-opening of
incision for graft failure post-operative Day 1)
(n=2)
Analysis
Analysed (n=59 incisions) “high-risk, Prevena
dressing”
complications, a total of 60 incisions receiving standard
dressings and 59 incisions receiving the Prevena dressing
were ultimately analyzed.
Demographics and risk factors. Table II identifies the
patients’ demographics and risk factors, including age,
BMI >30 kg/m2, presence of pannus, reoperation, use of
prosthetic graft, poor nutrition, immunosuppression, and
poorly controlled diabetes (hemoglobin A1c >8%), for
each group. In comparing the two high-risk groups, no
statistically significant difference was found for any
demographic or risk factors for wound complications.
Wound complications. The incidence of any wound
complications in each group (low risk, standard dressing;
high risk, standard dressing; high risk, Prevena) was 4.8%
(1/21), 26.7% (16/60), and 11.9% (7/59), respectively.
Table III reveals the incidence of major wound compli-
cations, the study’s primary end point, defined as wound
treatment requiring intravenous antibiotics, reoperation,
1748 Kwon et al Journal of Vascular Surgery
December 2018

Table II. Demographics of the patients standard dressing group, 11 of the 60 patients required
Low risk, High risk, reoperation (18.3%; total number of reoperations at
standard standard High risk, 30 days ¼ 24). The application of the Prevena dressing in
dressing dressing Prevena the high-risk group significantly decreased this incidence
(n ¼ 21) (n ¼ 60) (n ¼ 59) to 5 of the 59 patients (8.5%, P < .05; total number of
Male 15 (71) 36 (60) 26 (44) reoperations at 30 days ¼ 13). All reoperations were
Age, years (range) 71.2 (56-89) 67.4 (41-84) 64.6 (44-83) related to the treatment of wound infection.
Risk
Readmission. At 30 days, unplanned hospital readmis-
BMI >30, kg/m2 0 13 (21) 19 (32)
sion for groin wound complication occurred in 1 of the 21
Pannus 0 28 (47) 26 (44) low-risk control patients (4.8%; total number of read-
Reoperation 0 25 (42) 26 (44) missions at 30 days ¼ 1; Table V). In the high-risk, stan-
Prosthetic graft 0 39 (65) 38 (64) dard dressing group, 10 of the 60 patients required
Poor nutrition 0 1 (2) 1 (2) readmission (16.7%; total number of readmissions at
Immunosuppression 0 1 (2) 1 (2) 30 days ¼ 12). The application of the Prevena dressing in
Hemoglobin A1c >8% 0 4 (7) 4 (7) the high-risk group significantly decreased this incidence
BMI, Body mass index. to 4 of the 59 patients (6.8%; P < .04; total number of
Values are reported as number (%) unless otherwise indicated. reoperations at 30 days ¼ 5).

Cost analysis. The average variable hospital cost for the

or readmission, in each group. In low-risk controls, the
major wound complication rate was 4.8% (1/21). In the
high-risk group, this rate was 25% (15/60) when standard
dressings were used. Application of negative pressure
therapy significantly decreased this rate to 8.5% (5/59;
P ¼ .001).
Table III further reveals the incidence of infection and
the associated Szilagyi class in each group. In low-risk
controls, it was 4.8% (1/21 resulting in a major complica-
tion). In the high-risk cohort, this rate was 21.6% (12/60,
all of which resulted in a major complication). Negative
pressure therapy significantly decreased this rate to
10.1% (6/59; P ¼ .001), five of which resulted in a major
complication.
Table IV identifies wound culture results. High-risk
wounds in both treatment arms were characterized by
both single and multiple species infections, including
fungal infections. However, there was a prevalence of
facultative anaerobic species in the Prevena group.
LOS. The average LOS for the index admission for the low-
risk group, high-risk standard dressing group, and high-risk
Prevena group was 3.6 6 4.3 days (n ¼ 21; range, 1-20 days),
9.1 6 7.5 days (n ¼ 55; range, 2-29 days), and 10.0 6 11.5 days
(n ¼ 51; range, 1-57 days), respectively (Table V). The average
total of days spent in the hospital if the patient was read-
mitted within 30 days after the index procedure was
3.8 6 4.7 days (range, 1-22 days), 10.6 6 8.6 days (range,
2-30 days), and 10.6 6 12.2 days (range, 1-57 days) for these
groups, respectively. The application of the Prevena dressing
in the high-risk group did not significantly alter the index or
30-day total LOS compared with standard dressings.
index admission for the low-risk group, high-risk stan-
dard dressing group, and high-risk Prevena group was
$17,549 6 $13,403 (n ¼ 21; range, $7064-$63,438),
$30,678 6 $23,338 (n ¼ 55; range, $9071-$131,464), and
$29,292 6 $29,320 (n ¼ 51; range, $8816-$192,658),
respectively (Table V). The average total variable hospital
cost for admissions occurring within 30 days after the
index procedure was $17,599 6 $13,410 (range, $7064-
$63,438), $36,537 6 $28,889 (range, $9071-$131,464), and
$30,492 6 $30,678 ($8816-$192,658) for these groups,
respectively. The cost difference between the two high-
risk groups ($6045 less for the Prevena group) was not
statistically significant (P ¼ .11).
Bilateral groin incisions. A total of 25 patients under-
went operations involving bilateral groin procedures.
One of these patients was considered low risk and
received standard dressing for both incisions, which
healed without complication.
The remaining 24 patients were considered high risk for
complications and received a standard dressing on one
side and a Prevena dressing on the other side. Of those
receiving a standard dressing, there were nine total
(37.5%) and eight major (33%) wound complications.
Application of the Prevena dressing reduced the compli-
cation rate to five total (20.8%) wound complications, all
of which were major (P ¼ .19). Sensitivity analysis showed
that removal of the bilateral patients did not change the
main results. With regard to costs, the high-risk control
patients now had a mean cost of $36,337.46 vs
$34,246.67 for high-risk Prevena patients (mean cost
reduction of $2090.79).

Reoperation. At 30 days, unplanned return to the oper- DISCUSSION

ating room for groin wound complication occurred in 1 of The aim of this randomized prospective single-center
the 21 low-risk control patients (4.8%; total number of study was to evaluate the effect of negative pressure
reoperations at 30 days ¼ 1; Table V). In the high-risk, therapy on the healing of elective vascular surgery groin
Journal of Vascular Surgery Kwon et al 1749
Volume 68, Number 6

Table III. Wound complications at 30 days

Low risk, standard High risk, standard High risk, Prevena High risk, standard
dressing (n ¼ 21) dressing (n ¼ 60) dressing (n ¼ 59) vs Prevena, P value
Any 1 (4.8) 16 (26.7) 7 (11.9) .001
Dehiscence 0 1 1
Lymph leak 0 2 0
Infection 1 (4.8) 12 (21.6) 6 (10.1) .001
Hematoma 0 1 0
Major 1 (4.8) 15 (25) 5 (8.5) .001
Dehiscence 0 0 0
Lymph leak 0 2 0
Infection 1 (4.8) 12 (21.6) 5 (8.6) .001
Hematoma 0 1 0
Szilagyi class
1 2 (16.7) 1 (16.7)
2 1 (100) 3 (25) 2 (33.3)
3 7 (58.3) 3 (50)
Values are reported as number (%).

Table IV. Bacteriology of wound infections

High-risk, standard dressing High-risk, Prevena dressing
Bacteria species Gram negative Gram negative
Klebsiella pneumoniae Klebsiella oxytoca
Pseudomonas aeruginosa Serratia marcescens
Serratia marcescens Gram negative (facultative anaerobic)
Gram positive Proteus mirabilis
Staphylococcus aureus Enterobacter cloacae
Staphylococcus epidermidis Escherichia coli
Gram positive
Staphylococcus aureus
Streptococcus anginosus
Staphylococcus lugdunensis
Gram positive (facultative anaerobic)
Enterococcus faecalis
Enterococcus faecium (VRE)
Fungal species Candida glabrata Candida tropicalis
Candida albicans
VRE, Vancomycin-resistant enterococcus.

incisions compared with standard dressings during a
30-day period. The results of the study disproved the
null hypothesis; rather, application of negative pressure
therapy to groin incisions at high risk for complications
significantly decreased the rate of major wound compli-
cations, need for reoperation, and patient readmission.
LOS was not altered in high-risk patients. The therapy
was associated with a savings of more than $6000 per
index case.
Previous literature has suggested that negative
pressure therapy decreases wound complications. In
studying obese patients at risk for infection after median
sternotomy, Grauhan et al38 found a decrease in wound
infection from 16% to 4% (P ¼ .0266). Similarly,
Stannard et al36 observed a decrease in wound infection
from 19% to 10% (P ¼ .049) in patients randomized to
negative pressure therapy after open surgical treatment
of lower extremity blunt injury fractures. With regard to
vascular groin wound complications, Matatov et al40
retrospectively evaluated 99 patients (115 groin incisions)
and found the Prevena device to decrease postoperative
groin wound infection from 30% to 6% (P ¼ .0011).
The prospective, randomized study presented here
provides level 1 evidence for the previous findings
noted by Matatov. In randomizing groin incisions at
high risk for complications, this study observed a signifi-
cant decrease in major wound complications from 25%
to 8.5%. Similarly, wound infection (both major and
minor) was reduced from 21.6% to 10.1% with negative
pressure therapy.
1750 Kwon et al
Table V. Secondary end points at 30 days
Low risk,
standard dressing
LOS, days
Index admission 3.6 6 4.3
All admissions at 30 days 3.8 6 4.7
Reoperation 1 (4.8%)
Readmission 1 (4.8%)
Average variable cost
Index admission $17,549 6 $13,403
Total at 30 days $17,599 6 $13,410
LOS, Length of stay; NS, not significant.
This study furthers understanding of the impact of
negative pressure therapy by documenting significant
decreases in need for reoperation as well as for readmis-
sion. Interestingly, we did not observe a decrease in
either index or total 30-day LOS. The comorbidities
observed in our high-risk population contributed to a
significantly longer LOS (compared with low-risk
patients); however, this increase was not altered by the
decrease in wound complications afforded by negative
pressure therapy, suggesting that the major drivers for
LOS in this study relate to patients’ comorbidities rather
than to subsequent wound complications.
The results of another randomized single-center clinical
trial have recently been published by Lee et al.42 In this
study, which began accruing patients in 2014, there
were 102 patients risk stratified on the basis of reopera-
tion, obesity, or presence of tissue loss. These authors
observed a decrease in 30-day skin and soft tissue infec-
tion from 19% to 11% (P ¼ .24). The lower than expected
infection rate was thought to result in the study’s being
underpowered. Our observed infection rate in the high-
risk control group was higher, probably because of differ-
ences in risk factor stratification, and may account for
this study’s showing statistical significance. These
authors did show a benefit in terms of reduced LOS
but no difference in reoperation or readmission. Again,
this variation with this study may be attributable to a sig-
nificant difference in high-risk stratification.
This study furthers our knowledge in evaluating poten-
tial cost savings associated with negative pressure ther-
apy. Although the cost difference between the high-risk
groups was not statistically significant (P ¼ .11), a variable
hospital cost savings of more than $6000 per patient was
observed, including the costs of the device ($500 to
Thomas Jefferson University Hospital). This likely under-
estimates total cost savings as not included in our anal-
ysis were outpatient costs for treatment of infection
and future readmission penalties, both of which would
be reduced by the application of negative pressure
therapy.
Journal of Vascular Surgery
December 2018
High risk, High risk, High risk, standard
standard dressing Prevena dressing vs Prevena, P value
9.1 6 7.5 10.0 6 11.5 NS
10.6 6 8.6 10.6 6 12.2 NS
11 (18.3%) 5 (8.5%) .05
10 (16.7%) 4 (6.8%) .04
$30,678 6 $23,338 $29,292 6 $29,320 NS
$36,537 6 $28,889 $30,492 6 $30,678 NS
Not studied was the mechanism by which negative pres-
sure therapy reduced vascular groin wound complications.
Several hypotheses can be made in this regard. First, the
device placed within the sterile confines of the operating
room was in place for 5 days. As such, it may have provided
a more effective barrier function than standard dressings.
Second, the sponge used by the device is impregnated
with antibiotics (0.019% ionic silver). We qualitatively noted
differences in species type cultured from the wounds,
mainly an increase in facultative anaerobes in infections
in wounds treated with the device. The significance of
these differences, however, cannot be addressed in this
study. Third, active removal of incisional fluid might play
a role. Although we did not quantitate fluid removal by
the device, qualitative observation suggests that the
majority of high-risk wounds treated with the device
drained minimally during the 5 days of treatment
(ie, <50 mL total). Pachowsky et al37 observed a significant
decrease in seroma formation with the application of
negative pressure after total hip arthroplasty, suggesting
that edema and fluid control may be of benefit. Last, nega-
tive pressure therapy for open wounds has been demon-
strated to promote wound healing by modulation of
cytokines to an anti-inflammatory profile, promoting
angiogenesis, extracellular matrix remodeling, and deposi-
tion of granulation tissue.46 It is possible that similar mech-
anisms may be important in the closed incision.
The inclusion of patients undergoing bilateral proced-
ures was debated, knowing that evaluation with regard
to LOS and variable hospital costs would be confounded.
Nonetheless, these patients were included, largely for
their value as internal controls. In the 24 patients under-
going bilateral procedures, in which one side was treated
with standard dressing and the other Prevena, we
observed a 13% decrease (33% to 20%) in major wound
complications.
Study limitations. The trial was terminated after
randomizing 80% of the wounds suggested by power
analysis. We observed at that time a 67% reduction in
Journal of Vascular Surgery
Volume 68, Number 6
significant wound complications (P < .001) as well as
reduction in hospital variable costs meeting both
criteria for trial termination, meeting the predeter-
mined stop criteria. Nonetheless, it is recognized that
power analysis suggested randomization of 150
wounds rather than the 119 herein reported. Further-
more, a major limitation to the study was that it was
not a blinded study and therefore subject to observer
bias. Assessment of complications is qualitative, and
ultimate management of infections, such as opening
an infected wound, was left to the discretion of the
attending surgeon. Regarding generalizability of the
findings, the study was limited to a single center as
well as to a specific definition of high-risk vascular
groin wounds. Others may use different criteria for high
risk as was noted in the trial by Lee et al,42 and it is
recognized that not collecting data on other patient
comorbidities (ie, smoking status, chronic kidney dis-
ease, coronary artery disease, and chronic obstructive
pulmonary disease) as well as intraoperative data (ie,
operative time and blood loss) represents a limitation.
In addition, treatment of wound infection involving an
underlying vascular graft may differ between centers,
depending on desire for graft preservation, which may
result in different criteria for reoperation. These find-
ings, however, do appear consistent across other inci-
sion types (cardiac, orthopedic), thereby suggesting a
generalizable effect. In this regard, the authors are now
embarking on a multicenter, randomized trial to eval-
uate negative pressure therapy to decrease major
amputation wound complications. Last, it is acknowl-
edged that the method of randomization by coin toss,
although performed by the nurse practitioners
completely independent of the operating surgeon,
represents a limitation to the study.
CONCLUSIONS
Based on previous literature and this randomized
controlled trial, the application of negative pressure to
a closed groin incision appears to decrease the incidence
of wound complications, particularly in patients at high
risk for this common problem. It also appears that in
doing so, cost savings may be realized in terms of
decreased reoperation and readmission. The routine
use of this device for all high-risk groin incisions is
recommended.
AUTHOR CONTRIBUTIONS
Conception and design: BA, DS, DR, PD
Analysis and interpretation: DR, PD
Data collection: JK, CS, MM, SG, MA
Writing the article: JK, DR, PD
Critical revision of the article: JK, CS, MM, SG, MA, BA, DS,
DR, PD
Final approval of the article: JK, CS, MM, SG, MA, BA, DS,
DR, PD
Kwon et al 1751
Statistical analysis: DR
Obtained funding: Not applicable
Overall responsibility: PD
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Submitted Jan 15, 2018; accepted May 24, 2018.