Eur J Vasc Endovasc Surg (2018) 56, 442e448

Closed Incision Negative Pressure Therapy Reduces Surgical Site Infections in

Vascular Surgery: A Prospective Randomised Trial (AIMS Trial)
Alexander Gombert a,*, Michael Babilon b, Mohammad E. Barbati a, Andras Keszei c, Klaus T. von Trotha a, Houman Jalaie a,
Johannes Kalder a, Drosos Kotelis a, Andreas Greiner d, Stephan Langer b, Michael J. Jacobs a, Jochen Grommes a
a
European Vascular Centre Aachen-Maastricht, University Hospital Aachen, RWTH Aachen University, Germany
b
Department of Vascular Surgery Marienhospital Witten, Witten, Germany
c
Centre for Translational & Clinical Research Aachen, University Hospital Aachen, RWTH Aachen University, Germany
d
Department of Vascular Surgery, Charité University Hospital Berlin, Berlin, Germany

WHAT THIS PAPER ADDS

In this RCT, the closed incision negative pressure therapy device reduced superficial surgical site infections
following groin incisions in vascular surgery in comparison with standard wound dressings.

Background: Surgical site infections (SSIs) of the groin remain a crucial problem in vascular surgery, prompting great
interest in preventative techniques, such as closed incision negative pressure therapy (ciNPT). This prospective
randomised study aimed to assess the potential benefits of ciNPT application after groin incisions for vascular surgery.
Method: The study included 204 patients who underwent vascular surgery for peripheral artery disease (PAD) at
two sites between July 2015 and May 2017. These patients received post-operative treatment with ciNPT
(intervention group) or standard wound dressings (control group). After exclusion, 188 patients were assessed for
SSIs using the Szilagyi classification.
Results: The mean patient age was 66.6
9.4 years (range 43e85 years), and 70% were male (n ¼ 132).
Regarding PAD stage, 52% were stage IIB, 28% stage III, and 19% stage IV. Among the patients, 45% (n ¼ 85) had
had a previous groin incision. Bacterial swabs were performed in each case of suspected SSI (22.8% [43/188]),
while 76.7% (33/188) were negative, there were 5% [5/98] positive swabs in the intervention group and 5.5% [5/
90] in the control group). Antibiotics were given to 13.2% of the intervention group, and 31.1% of the control
group (p ¼ .004). The control group experienced more frequent SSIs (33.3%; 30/90) than the intervention group
(13.2%; 13/98; p ¼ .0015; absolute risk difference 20.1 per 100; 95% CI -31.9 to 8.2). This difference was based
on an increased rate of Szilagyi I SSI in the control group (24.6% vs. 8.1%, p ¼ .0012).
Conclusion: The results confirmed a reduced superficial SSI rate after vascular surgical groin incision using ciNPT
compared with standard wound dressings.
Ó 2018 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.
Article history: Received 9 January 2018, Accepted 18 May 2018, Available online 30 June 2018
Keywords: Surgical site infection, Groin incision, Vascular surgery, ciPNT, Prevena, RCT

INTRODUCTION series and single centre experiences. Benefits of ciNPT, such

Surgical site infections (SSIs) constitute a substantial
healthcare burden in terms of morbidity, mortality, and
increased costs.1e3 Vascular surgical procedures, including
lower extremity arterial surgery (LEAS), often involve stan-
dard access via a longitudinal groin incision, which is
frequently associated with SSI.4,5 Adherence to SSI pre-
vention measures can reduce their prevalence by up to
40%.6 Attention has recently focused on closed incision
negative pressure therapy (ciNPT) based on numerous case
* Corresponding author. European Vascular Centre Aachen-Maastricht,
Department of Vascular Surgery University Hospital Aachen,
Pauwelsstraße 30, 52074 Aachen Germany.
E-mail address: agombert@ukaachen.de (Alexander Gombert).
1078-5884/Ó 2018 European Society for Vascular Surgery. Published by
Elsevier B.V. All rights reserved.
https://doi.org/10.1016/j.ejvs.2018.05.018
as Prevena (KCI/Acelity San Antonio, TX, USA) include
reduced skin tension in the incision area and fluid removal.7
Using ciNPT, a significantly reduced rate of SSIs classified by
Szilagyi following LEAS has been reported in a retrospective
comparative study (30% control group vs. 3% intervention
group).8 Although a recent meta-analysis suggests that
these alternatives have benefits compared with standard
wound dressings regarding a reduced rate of SSI, the
existing data for the use of negative pressure devices de-
rives from few randomised trials with inconsistent re-
sults.7,9,10 Thus, there is presently no clear evidence
supporting the superiority of ciNPT compared with a stan-
dard wound dressing with regards to reducing the rate of
SSIs.11
In this study, a prospective randomised controlled trial
(RCT) was performed in two centres with the aim of
A Prospective Randomised Trial (AIMS Trial)
Figure 1. Flow chart showing patient inclusion and follow up.
comparing the results of incisional ciNPT versus standard
wound dressings following vascular surgical groin incision.
METHODS
Study design
This investigator initiated RCT was conceptualised and
observed by an independent clinical trial centre - the Centre
for Translational & Clinical Research Aachen (A-CTCA). The
quality and integrity of data assessment were continuously
assessed. Written informed consent was obtained pre-
operatively from all subjects, and the study was per-
formed in accordance with the Declaration of Helsinki. This
intervention study was approved by the German Federal
Institute for Drugs and Medical Devices (BfArM) and the
internal review board (EK 309/14), furthermore it is regis-
tered at clinicaltrials.gov (number NCT02395159).
Participants
The study included 204 patients who underwent vascular
surgery at two study centres between July 2015 and May
2017. Inclusion criteria were longitudinal groin incision for
vascular surgical procedures involving the arterial system of
the lower extremity or the iliac arteries. PAD was defined
according to the Fontaine classification. The eligibility of a
patient was determined by both a certified study surgeon
and a certified study nurse. Patients having had previous
vascular surgery via groin access were included and classified
as “redo surgery.” To be eligible for participation, patients
had to have a comorbidity profile including smoking (active
or past history), cardiac risk factors (e.g. hypertension, cor-
onary heart disease, or history of myocardial infarction), and
metabolic disorders (e.g. diabetes, dyslipidaemia,
443
hyperhomocysteinaemia, or chronic renal failure). Dyslipi-
daemia was defined as hypertriglyceridaemia (>150 mg/dL)
or hypercholesterolaemia (total cholesterol > 200 mg/dL).
Chronic kidney disease was defined as glomerular filtration
rate (GFR) < 60 mL/min/1.73 m2. Exclusion criteria were age
below 18 years, pregnancy, local skin infection, simultaneous
participation in another clinical trial, and immunosuppres-
sive medication. No emergency procedures were included.
When a groin incision was performed on both sides, only one
side was randomised and assessed for this study.
Randomisation
After pre-operative randomisation, patients in the inter-
vention group received ciNPT by application of a Prevena
Incision Management System (IMS) (KCI/Acelity San Antonio,
TX, USA). The control group received standard wound dres-
sing (Cosmopore, Hartmann, Heidenheim, Germany). The
randomisation sequence was computer generated using the
random allocation rule, and allocation was implemented
using a centralised web based system to ensure allocation
concealment. Data were collected prospectively via a paper
based and electronic case report form (CRF). Patients who
were randomised but did not receive a groin incision were
treated as screening failures and were excluded. Patients
who experienced early (within 48 h) occlusions of the treated
vessel requiring de novo surgery were classified as dropouts
and were also excluded. Fig. 1 presents a flow chart of the
study design according to the CONSORT criteria.
Blinding
The nature of the therapy meant that double blinded
treatment was not possible. Furthermore, blinding of the
444
involved vascular surgeons was not achievable. Wound
assessment was performed clinically, which means by sub-
jective appraisal. Yet, according to the recommendations of
Karanicolas et al. regarding blinding in surgical studies,
measures were taken a priori to minimise potential bias.12
Until the seventh day after surgery, each wound was
assessed by two physicians. From this point, the wound was
assessed by at least three professionals (triple assessment).
The involved wound care nurses were blinded. Further-
more, each wound was documented by photography. In
case of any complication, wound related or not, the sponsor
was informed. Additionally, the clinical trial centre and the
statistician of this externally monitored study were blinded.
Surgical procedure
Patients underwent pre-operative hair shaving and prepa-
ration with Poly Alcohol (Antiseptic, Pulheim, Germany) and
Braunoderm (Braun, Melsungen, Germany). Thirty minutes
before incision, patients received 1.5 g cefuroxime or if
allergic to penicillin, 600 mg clindamycin intravenously. Af-
ter surgery, the incision was closed in three separate layers
using resorbable suture material (Vicryl; Ethicon Inc, Som-
erville, NJ, USA). Skin closure was performed using an intra-
cutaneous resorbable suture (Monocryl; Ethicon Inc),
percutaneous non-resorbable suture (Ethilon; Ethicon Inc),
or skin stapler (Appose, Medtronic, Memphis TN, USA). No
antibiotic coated sutures were used.
After closure, the incision and surrounding skin were
clean and dried using sterile gauze. In the control group,
Cosmopore E (Hartmann, Heidenheim, Germany) was
applied as the wound dressing, which was changed daily.
Showering was not allowed for the first seven days after
surgery even if the incision had healed without any irrita-
tion. In the intervention group, Prevena was applied under
sterile conditions in the operation room (OR) following the
manufacturer’s instructions. Prevena exerts a continuous
negative pressure of 125 mmHg on the closed incision
during the time of application. The Prevena device was
removed 5e7 days post-operatively, after which no further
wound dressings were used in the intervention group un-
less SSIs occurred (Fig. 1).
Primary endpoint
The primary endpoint was the occurrence of surgical site
infections (SSI) assessed by the Szilagyi classification
following groin incisions as access for peripheral artery
surgery. Device related complications such as skin lacera-
tion, allergic reaction, reduced mobility, and negative
pressure related pain were assessed too.
Outcomes
Baseline characteristics were assessed and documented on
the day of enrolment. Follow up examinations were con-
ducted on the day of discharge (7 days after operation in
the absence of complications) and at 15 and 30 days after
surgery. If a SSI occurred, follow up was continued until the
Alexander Gombert et al.
wound healed. The effects of the ciNPT Prevena versus
standard wound dressings on the groin incision with regards
to wound healing and occurrence of SSIs were recorded.
Regardless of whether patients were randomised to the
intervention or control group, the occurrence of SSI was
assessed starting on the 7th day. Additionally, factors that
can potentially influence wound healing, including pre-
existing anticoagulation medication, body mass index
(BMI), comorbidity profile, length of stay in the hospital and
intensive care unit (ICU), total ventilation time, total oper-
ation time, type of vascular surgical procedure, and previ-
ous groin incisions were recorded. The need for antibiotic
treatment, the use of modern wound management,
requirement for additional surgical procedures, and micro-
biological findings were documented. Antibiotics were given
primarily based on clinical evaluation of the groin incision
and were documented from the first day of treatment.
When an SSI was suspected, blood samples and wound
swabs were taken for microbiological examination, and
additional follow up examinations were performed.
SSI were clinically assessed and classified using the Szi-
lagyi classification (grades IeIII).13 Grade I was limited to
the dermis and included lymphatic leakage from the closed
incision, grade II infections extended to the subcutaneous
skin layers, and grade III infections involved the arteries. In
cases of SSI deterioration, the patient was assigned a higher
grade. Post-surgical complications were separately docu-
mented. In the event of severe complications, such as Szi-
lagyi grade II and III SSIs, myocardial infarction, or hospital
re-admission because of SSI, the study sponsor was
informed within 48 h. Wound assessment was considered
complete when the wound was closed, on the occurrence
of SSI, or upon the patient’s death.
Statistics
Descriptive analyses of study data were performed using
appropriate summary statistics for discrete and continuous
data; mean, standard deviation, median, 1st and 3rd quar-
tiles were used for continuous variables. Frequencies and
percentages were used for categorical variables. Indepen-
dent t tests and KruskaleWallis tests were used to test
continuous variables.
The outcome measure for primary analysis was any
occurrence of infection classified as Szilagyi I or higher.
Analysis of treatment was performed as intention to treat
analysis. Patients with no recorded infection information
were assumed to have no infections (n ¼ 11). To evaluate
effect measures, the study treatments were compared and
the incidence risk ratio, absolute risk difference, and odds
ratio along with 95% CI calculated. A secondary analysis can
be found in the Supplementary material. Variables were
chosen based on clinical consideration of possible associa-
tion with wound infection. To further evaluate the robust-
ness of the primary analysis, a sensitivity analysis was
performed, in which patients in the intervention group
lacking infection data were assumed to have developed an
infection (n ¼ 7), and patients in the control group lacking
A Prospective Randomised Trial (AIMS Trial) 445

Table 1. Characteristics of patients in the study and control groups.

Study group (n ¼ 98) Control group (n ¼ 90) p value
Age, years, mean (s.d.) 67.9 (10.1) 65.2 (8.4) .04
Male sex 70 (71) 62 (69) .70
BMI, kg/m2, mean (s.d.) 26.9 (4.8) 25.7 (4.6) .09
Smoker 47 (48) 64 (71) .001
Arterial hypertension 98 (100) 86 (96) .05
Coronary heart disease 56 (57) 44 (49) .26
History of myocardial infarction 22 (22) 24 (27) .50
History of stroke 18 (18) 14 (16) .61
Diabetes 42 (43) 22 (24) .01
Dyslipidaemia 94 (96) 82 (91) .18
Chronic kidney disease 32 (33) 26 (29) .58
Baseline creatinine, mg/dL, median (1st; 3rd 1.4 (1.2; 1.7) 1.4 (1.2; 1.6) .86
quartile)
Baseline urea, mg/dL, mean (s.d.) 46.5 (17.9) 52.4 (23.7) .30
COPD 24 (25) 17 (19) .35
Anticoagulant medicationa 8 (8) 7 (8) .92
Acetylsalicylic acid medication 79 (81) 78 (87) .26
Statin medication 67 (68) 62 (69) .94
Steroid medication 4 (4) 4 (4) 1.00
ASA III or greater 87 (89) 80 (89) .93
PAD stage II B 50 (51) 49 (54$4) .52
PAD stage III 29 (29$5) 24 (26$6)
PAD stage IV 19 (19) 17 (19)
History of vascular access via groin incision 46 (47) 39 (43) .62
History of surgical wound complication following 14 (14) 6 (7) .10
groin incision
Data are presented as count (percentage) unless noted otherwise. BMI ¼ body mass index; COPD ¼ chronic obstructive pulmonary
disease; PAD ¼ peripheral artery disease; ASA ¼ American Society of Anesthesiology.
a
Phenprocoumon or rivaroxaban.
infection data were assumed to have developed no infec- in the intervention group, and 31.1% (n ¼ 28) in the control
tion (n ¼ 4). group (p ¼ .004). Two cases of SSI grade I, one in the
Sample size calculation was based on previously reported intervention and one in the control group, received no
differences in the occurrence of wound infections among antibiotic treatment based on clinical decision. All further
patients treated with and without Prevena IMS, which were
used to estimate the possible range of plausible treatment Table 2. Procedural details in the study and control groups.
effect.These have not been used for estimating proportions in
Study group Control group p
the control group; here informal estimates of proportions
(N ¼ 98) (N ¼ 90) value
have been applied.8,14 The differences between the treatment Bypass/patch material
groups were calculated using a type 1 error of 0.05, power of Venous 13 (13$2) 9 (10) .5
0.8, and a two tailed Fisher’s test as modified by Boschloo Dacron 12 (12$2) 10 (11$1) .82
test.15 With an expected outcome of 3% in the intervention PTFE 34 (34$6) 32 (35$5) 1
group and a treatment difference of 0.14 (17% outcome in the Xenogen 29 (29$6) 30 (33$3) 1
control group), the required sample size was 71 patients per None (including 10 (10$2) 9 (10) 1
treatment group. Assuming a 10% dropout rate and a thrombectomy)
doubling of the outcome proportion among dropouts Femoral EA including 48 (50) 41 (45$5) .66
compared with the proportion expected in the control group, patch plasty
P1 bypass 22 (22$4) 19 (21$1) .86
102 patients per group were included in the study. R software,
P3/crural bypass 9 (9$1) 9 (10) 1
version 3.3.2 was used for the analysis (R Core Team, 2016).
Aortobifemoral 16 (16$3) 13 (14$4) .84
prosthesis
RESULTS Thrombectomy 3 (3) 8 (8$8) .12
Treated side
Study population Right 43 (43$8) 39 (43$3) 1
Table 1 presents detailed patient information. Left 40 (40$8) 37 (41$1) 1
Both 15 (15$3) 14 (15$5) 1
Data are presented as count (percentage). EA ¼ endarterectomy;
Procedural and peri-operative data
P1 ¼ popliteal artery above the knee; P3 ¼ popliteal artery below
Antibiotic treatment was administered for SSI following the knee. p values were calculated using a two tailed Fishers’ exact
21.8% of the procedures (n ¼ 41), including 13.2% (n ¼ 13) test. p < .05.
446 Alexander Gombert et al.

Table 3. Operative and post-operative data from the intervention Table 5. Details of the wound swab.
and control groups. Intervention group Control group p
Category Intervention Control p (N ¼ 98 (%)) (N ¼ 90 (%)) value
group group value Bacteria
(n ¼ 98) (n ¼ 90) Staphylococcus 2 (2) 0 1
Operation time, min 146 (111; 149 (96; .22 epidermidis
204) 185) Staphylococcus 1 (1) 0 1
Length of intensive care stay, 1 (1; 2) 1 (1; 1) .05 capitis
days, n ¼ 24 Staphylococcus 2 (2) 4 (4.4) .42
Length of ventilation, hours, 3.1 (1.5) 3.1 (1.7) .90 aureus (MSSA)
mean (s.d.) Streptococcus 0 1 1
Length of hospital stay, days 8 (7; 11) 8 (6; 9) .85 pyogenes
C reactive protein, mg/L 55 (24; 97) 39 (19; .31a No bacteria in the 8 (8.1) 25 (27.7) .05
66) swab
Leucocytes/mL, mean (s.d.) 10.5 (4$1) 9.0 (2.6) .05a MSSA ¼ methicillin sensitive Staphylococcus aureus. p values were
Alternative wound dressing 13 (13) 21 (23) .11b calculated using a two tailed Fishers’ exact test. p < .05.
Antibiotic treatment 13 (13.2) 28 (31.1) .004
Surgical revision 5 (5.1) 6 (6.6) .76 control group (26.7% [n ¼ 24] vs. 8.1% [n ¼ 8], p ¼ .0012).
Data are presented as count (percentage) or median (1st; 3rd The absolute risk difference (RD) for SSI assessed by Szilagyi
quartiles) unless otherwise indicated. p values were determined classification was 20.07 per 100 (95% CI -31.9 to 8.2). In
by KruskaleWallis tests unless otherwise noted. the sensitivity analysis for SSI in a worst case scenario, the
a
Wald tests from linear models using generalised least squares occurrence of SSI was assumed in patients in the inter-
with time and treatment effects. vention group lacking data on infections, and no SSI
b
Chi-square test for equality of proportions (continuity corrected). occurrence was assumed in patients in the control group
C reactive protein and leucocytes were measured post-operatively. lacking data on infections. The results of this analysis
showed a lower SSI incidence in the study group (p ¼ .049;
details concerning the procedural and peri-operative data RD -12.9 per 100; 95% CI -25.5 to 0.33).
can be found in Tables 2 and 3. A separate analysis of both centres was conducted. At
site 1 (N ¼ 90), significantly more SSI occurred in the
control group (n ¼ 12; 29%) than in the intervention group
Surgical site infections (n ¼ 2; 4%; p ¼ .0012; RD -25.2 per 100; 95% CI -40.2
Table 4 presents detailed information regarding the SSI. to 10.2). At site 2 (N ¼ 98), more SSIs were also observed
Table 5 presents all details concerning the swabs. in the control group (n ¼ 18; 36%) than in the intervention
Regarding the primary endpoint of this study, the group (n ¼ 11; 22%), but the difference was not significant
occurrence of SSI assessed by the Szilagyi classification, the (p ¼ .18; RD -14.3 per 100; 95% CI -32.1 to 3.6). The inci-
analysis revealed significantly more SSI in the control group dence of SSIs was similar between patients with previous
than the intervention group (p ¼ .0015).This difference was groin incisions (21%; n ¼ 18/85) and patients without
previous groin incision (24%; n ¼ 24/103; p ¼ .727). Within
mainly based on an increased rate of Szilagyi I SSI in the
the subset of patients with previous groin incisions, the rate
of SSIs was significantly higher in the control group
Table 4. Surgical site infections in the intervention and control compared with the intervention group (p ¼ .016; RD -22.5
groups. per 100; 95% CI -39.8 to 5.2).
Intervention Control p value Additionally the SSI rates among different subgroups
group group were compared, details can be found in Table 4.
(N ¼ 98 (%)) (N ¼ 90 (%)) Regarding any negative effect of the ciNPT on wound
Szilagyi all 13 (13.2) 30 (33.3) .0015a
healing conditions in the intervention group, potentially
Szilagyi I 8 (8.1) 24 (26.7) .0012a
related complications were assessed as described in the
Szilagyi II 5 (5.1) 4 (4) 1
Szilagyi III 0 (0) 2 (2.2) 1 methods section. No such complications were observed in
Age > 75 years 4/25 (16) 3/13 (23) .67 this trial. No failure of the device could be observed within
BMI > 25 kg/m2 10/59 (17) 25/50 (50) <.001a this study.
PAD score  3 2/46 (4) 17/42 (40.4) <.001a
Previous groin 5/46 (10.8) 13/39 (33.3) .016a DISCUSSION
incision
Diabetes 6/42 (14) 8/22 (36) .06 SSI remains an unresolved problem leading to increased
CKD 5/32 (16) 7/26 (27) .34 morbidity, mortality, and economic burden.16e18 Therefore,
Data are presented as count (percentage). p values were reduction of SSI is still of great interest in daily practice.
calculated using a two tailed Fishers’ exact test. CKD ¼ chronic A recent prospective study confirmed that ciNPT use for
kidney disease; PAD ¼ peripheral artery disease; BMI ¼ body groin incisions was associated with significantly reduced
mass index. SSIs for the first 7 days of application (p < .0005), with a
a
p < .05. subsequent loss of effectiveness.7 Moreover, in their
A Prospective Randomised Trial (AIMS Trial)
consensus paper, Willy et al. recommend individualised
ciNPT in patients at high risk of SSI.19 However, some
randomised studies and systematic reviews do not show
that ciNPT application is associated with reduced SSIs or
improved wound healing rate.20,21 Several studies have
investigated different beneficial aspects of ciNPT, animal
studies describe improved mechanical properties and a
narrower scar in the deep dermis 40 days after surgery with
ciNPT as well as reduced activity of genes associated with
tissue hypoxia and local inflammation.22,23
The present RCT examined the potential benefits of ciNPT
as a peri-operative preventive procedure with regards to SSI
occurrence. The analysis revealed that patients in the
intervention group had a significantly reduced SSI rate
compared with control patients. This suggests that the use
of ciNPT for groin incisions in PAD patients may be a valu-
able option. Notably, the majority of SSI was classified as
Szilagyi I, showing a significantly lower rate in the inter-
vention group compared with the control group. Regarding
Szilagyi II and III SSIs, which occurred in 5.8% (n ¼ 11) of all
procedures, no difference between both groups could be
observed. Furthermore, no difference regarding positive
bacterial swabs between the groups could be observed. SSI
classified as Szilagyi I are known to be less frequently
related to positive culture results.24
A lower SSI rate with ciNPT within subgroups having a
greater risk of wound infections, such as patients with PAD
stage 3, BMI >25 kg/m2, and previous groin incision was
found. In keeping with the recommendation of Willy et al.,
this finding supports the selective application of ciNPT in
high risk patients.19 With regard to the need for antibiotic
treatment, a higher frequency was observed in the control
group, according to the increased rate of SSI. Taken
together, the results imply that the use of ciNPT might be
useful in daily practice to reduce the rate of SSI.
Limitations
Despite all efforts which were defined a priori to enable an
objective assessment of the wound healing, the lack of
blinding of this surgical study has to be mentioned as po-
tential source of assessment bias. Furthermore, the present
findings were insufficient to draw conclusions regarding the
impact of ciNPT on SSIs classified as Szilagyi II and III,
because of the low number of these complications. A larger
RCT might enable separate analysis of these more severe
forms of SSI.
As wound assessment in the intervention group was only
possible after removal of the ciNPT (5e7 days), wound
evaluation with regard to SSI started after this period for
both groups.
The low backup of assessed SSI by bacterial culture results
must be mentioned. Finally, even if the funder of the study
was not involved in any part of the study, industrial funding
has to be seen as a potential source of bias. With regards to
the limitations of the present study, the pending results of the
presently ongoing studies may help in further evaluation of
the use of ciNPT after vascular access related groin incisions.
447
CONCLUSION
The present prospective randomised trial confirmed that
the use of ciNPT rather than standard wound dressing after
groin incision as access for vascular surgery was associated
with a reduced rate of superficial SSI classified by Szilagyi,
suggesting that ciNPT may be useful for reducing the SSI
rate among high risk patients.
CONFLICT OF INTEREST
This investigator-initiated trial has been funded by Acelity,
San Antonio, TX, USA. Dr. Gombert received travel grants in
2017 and 2018.
FUNDING
This investigator initiated trial was funded by Acelity, San
Antonio, TX, USA. The funder of this investigator initiated
trial had no role in study design, data collection, data
analysis, data interpretation or writing of the article. The
corresponding author had full access to all data from the
trial and had final responsibility for the results on submis-
sion for publication.
APPENDIX A. SUPPLEMENTARY DATA
Supplementary data related to this article can be found at
https://doi.org/10.1016/j.ejvs.2018.05.018.
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