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Editor's Choice – Systematic Review and Meta-Analysis of Wound Adjuncts for the Prevention of Groin Wound Surgical Site Infection in Arterial Surgery

Open ArchivePublished:January 07, 2021DOI:https://doi.org/10.1016/j.ejvs.2020.11.053

      Objective

      Groin incision surgical site infections (SSIs) following arterial surgery are common and are a source of considerable morbidity. This review evaluates interventions and adjuncts delivered immediately before, during, or after skin closure, to prevent SSIs in patients undergoing arterial interventions involving a groin incision.

      Data sources

      MEDLINE, EMBASE, and CENTRAL databases were searched.

      Review methods

      This review was undertaken according to established international reporting guidelines and was registered prospectively with the International prospective register of systematic reviews (CRD42020185170). The MEDLINE, EMBASE, and CENTRAL databases were searched using pre-defined search terms without date restriction. Randomised controlled trials (RCTs) and observational studies recruiting patients with non-infected groin incisions for arterial exposure were included; SSI rates and other outcomes were captured. Interventions reported in two or more studies were subjected to meta-analysis.

      Results

      The search identified 1 532 articles. Seventeen RCTs and seven observational studies, reporting on 3 747 patients undergoing 4 130 groin incisions were included. A total of seven interventions and nine outcomes were reported upon. Prophylactic closed incision negative pressure wound therapy (ciNPWT) reduced groin SSIs compared with standard dressings (odds ratio [OR] 0.34, 95% CI 0.23 – 0.51; p < .001, GRADE strength of evidence: moderate). Local antibiotics did not reduce groin SSIs (OR 0.60 95% CI 0.30 – 1.21 p = .15, GRADE strength: low). Subcuticular sutures (vs. transdermal sutures or clips) reduced groin SSI rates (OR 0.33, 95% CI 0.17 – 0.65, p = .001, GRADE strength: low). Wound drains, platelet rich plasma, fibrin glue, and silver alginate dressings did not show any significant effect on SSI rates.

      Conclusion

      There is evidence that ciNPWT and subcuticular sutures reduce groin SSI in patients undergoing arterial vascular interventions involving a groin incision. Local antibiotics did not reduce groin wound SSI, although the strength of this evidence is lower. No other interventions demonstrated a significant effect.

      Keywords

      This review supports closed incision negative pressure wound therapy (ciNPWT) as an effective intervention for preventing both superficial and deep surgical site infections (SSIs) in groin incisions following arterial intervention. Available evidence suggests local antibiotics do not reduce overall SSI rates, but may reduce superficial SSIs, however data are heterogenous and lacking. Subcuticular sutures, as opposed to other methods of closure, appear to reduce SSIs. The cost effectiveness of ciNPWT, and efficacy of local antibiotics (for both superficial and deep SSI) in vascular groin wounds, are research questions that should be addressed with future randomised trials.

      Introduction

      Surgical site infections (SSIs) are a frequent complication of operative procedures.
      World Health Organization
      Global guidelines for the prevention of surgical site infection.
      ,
      National Institute for Health and Care Excellence
      Surgical site infections: prevention and treatment (NG125).
      SSI rates in vascular surgery are high, attributable in part to the comorbid cohort of patients undergoing surgery with a high prevalence of diabetes, smoking, and frailty.
      • van de Weijer M.A.J.
      • Kruse R.R.
      • Schamp K.
      • Zeebregts C.J.
      • Reijnen M.M.P.J.
      Morbidity of femoropopliteal bypass surgery.
      ,
      • Wiseman J.T.
      • Fernandes-Taylor S.
      • Barnes M.L.
      • Scott Saunders R.
      • Saha S.
      • Havlena J.
      • et al.
      Predictors of surgical site infection after hospital discharge in patients undergoing major vascular surgery.
      Groin wounds are particularly susceptible to developing infection, partly due to the risk of iatrogenic lymphatic injury and partly due to the skin flora in the groin skin crease, owing to its proximity to the external genitalia and the anal canal.
      • Grice E.A.
      • Segre J.A.
      The skin microbiome.
      Despite this, the groin is one of the most frequently employed incisions in vascular surgery, used to gain access to the femoral vessels in a wide range of vascular operations.
      • van de Weijer M.A.J.
      • Kruse R.R.
      • Schamp K.
      • Zeebregts C.J.
      • Reijnen M.M.P.J.
      Morbidity of femoropopliteal bypass surgery.
      ,
      • Wiseman J.T.
      • Fernandes-Taylor S.
      • Barnes M.L.
      • Scott Saunders R.
      • Saha S.
      • Havlena J.
      • et al.
      Predictors of surgical site infection after hospital discharge in patients undergoing major vascular surgery.
      SSIs in the groin can have devastating consequences, particularly if prosthetic material is placed within the groin, as these grafts are at risk of blow out and catastrophic haemorrhage, posing risk to both life and limb.
      • Smith A.D.
      • Hawkins A.T.
      • Schaumeier M.J.
      • de Vos M.S.
      • Conte M.S.
      • Nguyen L.L.
      Predictors of major amputation despite patent bypass grafts.
      ,
      • Siracuse J.J.
      • Nandivada P.
      • Giles K.A.
      • Hamdan A.D.
      • Wyers M.C.
      • Chaikof E.L.
      • et al.
      Prosthetic graft infections involving the femoral artery.
      Reported rates of vascular groin wound SSI vary widely, ranging from 2.6% and 31%.
      • Wiseman J.T.
      • Fernandes-Taylor S.
      • Barnes M.L.
      • Scott Saunders R.
      • Saha S.
      • Havlena J.
      • et al.
      Predictors of surgical site infection after hospital discharge in patients undergoing major vascular surgery.
      ,
      • Kuy S.
      • Dua A.
      • Desai S.
      • Dua A.
      • Patel B.
      • Tondravi N.
      • et al.
      Surgical site infections after lower extremity revascularization procedures involving groin incisions.
      ,
      • Trinidad B.
      • Rybin D.
      • Doros G.
      • Eslami M.
      • Tan T.W.
      Factors associated with wound complications after open femoral artery exposure for elective endovascular abdominal aortic aneurysm repair.
      Methods to reduce SSIs have been subject to national and international guidelines.
      World Health Organization
      Global guidelines for the prevention of surgical site infection.
      ,
      National Institute for Health and Care Excellence
      Surgical site infections: prevention and treatment (NG125).
      Some factors thought or known to be important in the development of groin SSIs, such as selection of a longitudinal vs. oblique groin incision, are in part determined by the surgical procedure being performed and cannot be used in all patients.
      • Canteras M.
      • Baptista-Silva J.C.
      • do Carmo Novaes F.
      • Cacione D.G.
      Transverse versus vertical groin incision for femoral artery approach.
      However, interventions or adjuncts to reduce groin wound SSIs just before, during, or after skin closure, have not been subject to the same rigorous analyses, and practice regarding these is therefore variable.
      The aim of this systematic review and meta-analysis was therefore to provide a comprehensive overview of the evidence from any study type, by separately evaluating any wound interventions or adjuncts aimed at preventing groin wound SSIs, compared with standard practice, in patients undergoing arterial vascular intervention through a groin incision.

      Materials and methods

      This systematic review and meta-analysis was conducted and is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.
      • Moher D.
      • Liberati A.
      • Tetzlaff J.
      • Altman D.G.
      • Altman D.
      • Antes G.
      • et al.
      Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.
      It was registered prior to commencement with the International prospective register of systematic reviews (PROSPERO) (CRD42020185170).

      Inclusion and exclusion criteria, data sources, and search terms

      Eligible studies were randomised controlled trials (RCTs), cohort studies, and case series (prospective and retrospective) examining any wound intervention or adjunct aimed at reducing the rate of SSI compared with standard care or placebo in patients aged 18 or older undergoing arterial vascular procedures through a groin incision (including access for an endovascular procedure). Interventions or adjuncts were considered suitable for inclusion if they were delivered or given just before, during, or just after closure of the skin incision. Studies were excluded if the SSI outcome was not specific to the groin incision, if they reported venous or cardiac procedures, if pre-operatively the surgical field was already infected (e.g., infected pseudo-aneurysm repair), if no SSI data were reported, if no English version of the abstract was available, or if full results were pending publication. Review articles and meta-analyses were included as eligible for the purpose of screening their reference lists to identify further eligible studies. A search of the grey literature was not conducted.
      The MEDLINE, EMBASE, and CENTRAL databases were searched on the 25 April 2020 using the following search terms: ([SSI OR SSIs OR surgical site infection OR wound infection OR post-operative infection] AND [negative pressure OR negative-pressure OR vacuum OR suction OR dressing OR dressings OR topical OR local OR powder OR gauze OR sponge OR beads OR wash OR lavage OR irrigation OR suture OR antimicrobial OR antibiotic OR antibiotics OR adjunct OR adjuncts] AND [vascular OR arterial OR PAD OR PVD OR ischaemia OR limb OR CLTI OR CLI OR aneurysm OR AAA OR EVAR] AND [groin OR femoral]). No restrictions on date or publication type were used. Duplicate articles were removed prior to title and abstract screening. Full text screening was undertaken by two reviewers to determine eligibility. The references and related articles of the remaining articles and relevant review publications were screened by two reviewers for eligible studies, and any disagreements were settled by consensus with a third reviewer.

      Review methods

      The primary outcome was the rate of SSI, defined at any time point after surgery. Secondary outcomes included superficial and deep SSI rates, surgical or radiological re-intervention to manage SSI, re-admission to hospital, lymph complications or seroma, wound dehiscence, length of hospital stay, haematoma, complications of wound adjuncts (including bleeding complications), cost, vascular disease treated (occlusive, aneurysmal, trauma), incision type (longitudinal, oblique), and details of peri-operative SSI reducing measures (antibiotic prophylaxis, skin preparation, skin shaving, temperature, glycaemic control).
      Data were organised and analysed by wound adjunct (closed incision negative pressure wound therapy [ciNPWT], local antibiotics, wound drain, platelet rich plasma, subcuticular closure, fibrin glue, silver alginate dressings). Data extraction and quality assessment were performed by two reviewers independently (B.L.G., G.D., N.D.); discrepancies were adjudicated on by a third reviewer (J.S.). The data collection tool was drafted, trialled, and refined to ensure capture of all relevant data. Extracted data included study type, basic patient demographic, sample size, pathology treated, intervention details, control details, follow up protocol, definition of SSI used, and secondary outcomes assessed. RCTs were subject to assessment using the Cochrane Collaboration’s risk of bias tool,
      • Sterne J.A.C.
      • Savovic J.
      • Page M.J.
      • Elbers R.G.
      • Blencowe N.S.
      • Boutron I.
      • et al.
      ToB 2: a revised tool for assessing risk of bias in randomised trials.
      and cohort studies were assessed using the Newcastle–Ottawa Scale (NOS).
      • Wells G.A.
      • Shea B.
      • O’Connell D.
      • Peterson J.
      • Welch V.
      • Losos M.
      • et al.
      The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses.
      Outcomes contributing to meta-analyses were subjected to grading of recommendations, assessment, development, and evaluations (GRADE) assessment. Risk of bias was based on the Cochrane Collaboration’s risk of bias tool and NOS; inconsistency was based on evidence of heterogeneity; indirectness was based on the comparability of the studies’ populations, interventions, comparators, and outcomes; imprecision was based on visually assessing the confidence intervals and publication bias was based on visual assessment of funnel plots.

      Statistical analyses

      When studies reported multiple arms, the primary comparison was between intervention and standard care (or placebo). Outcomes reported by two or more studies were considered for meta-analysis. Heterogeneity was conveyed with the I2 statistic (a value higher than 50% considered to indicate significant heterogeneity). The Mantel–Haenszel method with random effects was used for dichotomous outcomes, and results were reported as odds ratios (OR) with 95% confidence intervals (CIs). For continuous outcomes, the inverse variance method was used with random effects and results reported in standard mean difference (SMD) with 95% confidence intervals. Sensitivity analyses were performed based on critical review of the available data for each wound intervention rather than planned a priori. A p value < .05 was considered statistically significant. Analyses were performed using Review Manager version 5.3.5 (The Cochrane Collaboration, Copenhagen).

      Results

      A total of 1 532 articles were identified in the initial search. Following title and abstract review, 124 were eligible for full text review. A PRISMA flow diagram is shown in Fig. 1. Twenty-four articles met the inclusion criteria and were accessed for data extraction, of which 17 were RCTs and seven were observational studies. Seven different interventions were assessed in these studies.
      Figure 1
      Figure 1Flow diagram of literature search of randomised controlled trials (RCTs) and observational studies reporting patients with groin incisions for arterial exposure to define surgical site infection rates and other outcomes.

      Demographic details

      Eligible studies were published between 1980 and 2020. A total of 4 130 groin incisions performed in 3 747 patients were reported upon, 2 528 of which were male (67.5%). Follow up ranged from five to 365 days, with a weighted mean of 49.4 days (95% CI 46.7 – 52.3). Nine outcomes were reported on. All studies reported SSI outcomes, and lymph leak or seroma were reported in nine studies, haematoma in eight studies, wound dehiscence in seven studies, length of hospital stay (LOS) in six studies, re-admission in three studies, re-operation (for any reason) in three studies, cost in two studies and allergic reaction in one study. Definitions of SSI varied between studies (Table 1).
      Table 1Summary of baseline study demographics of 24 studies evaluating wound adjuncts aimed at preventing groin wound surgical site infection (SSI) following arterial surgery
      Topic and first authorStudy type
      1 = randomised control trial; 2 = observational
      CentresPatients/incisions – nInterventions/incisions – nControls/incisions – nPathology treated
      1 = occlusive peripheral arterial disease; 2 = aneurysmal disease; 3 = trauma.
      Follow up – dOutcomes
      1 = SSI; 2 = lymph leak/seroma; 3 = haematoma; 4 = wound dehiscence; 5 = length of stay in hospital; 6 = re-admission; 7 = re-operation; 8 = cost; 9 = allergic reaction.
      SSI classification/definition
      ciNPWT
      Karl (2013)
      • Karl T.
      • Woeste S.
      Vermeidung von inguinalen Wundheilungsstörungen in der Gefäßchirurgie: Ergebnisse der Anwendung eines epidermalen Unterdrucksystems (PREVENATM).
      1Single100/1005050NDND1ND
      Matatov (2013)
      • Matatov T.
      • Reddy K.N.
      • Doucet L.D.
      • Zhao C.X.
      • Zhang W.W.
      Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients.
      2Single90/11541/5249/631, 2, 335.51Szilagyi
      Koetje (2015)
      • Koetje J.H.
      • Ottink K.D.
      • Feenstra I.
      • Fritschy W.M.
      Negative pressure incision management system in the prevention of groin wound infection in vascular surgery patients.
      2Single90/9040501, 23651Szilagyi
      Sabat (2016)
      • Sabat J.
      • Tyagi S.
      • Srouji A.
      • Pechman D.
      • Gupta A.M.
      • Lucido D.
      • et al.
      IP123. Prophylactic negative-pressure therapy for femoral incision in vascular surgery: preliminary results of a prospective, randomized trial.
      1Single49/63ND/30ND/33ND1221, 4ND
      Fleming (2017)
      • Fleming C.A.
      • Kuteva M.
      • O’Hanlon K.
      • O’Brien G.
      • McGreal G.
      Routine use of PICO dressings may reduce overall groin wound complication rates following peripheral vascular surgery.
      2Single151/15173781, 2421, 2, 3, 4, 5, 8Defined by study conductors
      Lee (2017)
      • Lee K.
      • Murphy P.B.
      • Ingves M.V.
      • Duncan A.
      • DeRose G.
      • Dubois L.
      • et al.
      Randomized clinical trial of negative pressure wound therapy for high-risk groin wounds in lower extremity revascularization.
      1Single102/10253491901Szilagyi, CDC
      Pleger (2017)
      • Pleger S.P.
      • Nink N.
      • Elzien M.
      • Kunold A.
      • Koshty A.
      • Böning A.
      Reduction of groin wound complications in vascular surgery patients using closed incision negative pressure therapy (ciNPT): a prospective, randomised, single-institution study.
      1Single100/129ND/58ND/711, 2301Szilagyi
      Engelhardt (2018)
      • Engelhardt M.
      • Rashad N.A.
      • Willy C.
      • Müller C.
      • Bauer C.
      • Debus S.
      • et al.
      Closed-incision negative pressure therapy to reduce groin wound infections in vascular surgery: a randomised controlled trial.
      1Single132/13264681, 2421Szilagyi
      Gombert (2018)
      • Gombert A.
      • Babilon M.
      • Barbati M.E.
      • Keszei A.
      • von Trotha K.T.
      • Jalaie H.
      • et al.
      Closed incision negative pressure therapy reduces surgical site infections in vascular surgery: a prospective randomised trial (AIMS Trial).
      1Multiple188/18898901, 2301, 5Szilagyi
      Kwon (2018)
      • Kwon J.
      • Staley C.
      • McCullough M.
      • Goss S.
      • Arosemena M.
      • Abai B.
      • et al.
      A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications.
      1Single119/11959601, 2301, 2, 3, 4, 5, 6, 8Szilagyi
      Hasselmann (2020)
      • Hasselmann J.
      • Björk J.
      • Svensson-Björk R.
      • Acosta S.
      Inguinal Vascular Surgical Wound Protection by Incisional Negative Pressure Wound Therapy: a randomized controlled trial – INVIPS Trial.
      1Single139/158ND/78ND/801, 2901, 2, 3, 4, 7CDC, ASEPSIS
      Local antibiotics
      Pitt (1980)
      • Pitt H.A.
      • Postier R.G.
      • MacGowan W.A.L.
      • Frank L.W.
      • Surmak A.J.
      • Sitzman J.V.
      • Bouchier-Hayes D.
      Prophylactic antibiotics in vascular surgery.
      1Single205/20554621281Szilagyi
      Mohammed (2013)
      • Mohammed S.
      • Pisimisis G.T.
      • Daram S.P.
      • Bechara C.F.
      • Barshes N.R.
      • Lin P.H.
      • et al.
      Impact of intraoperative administration of local vancomycin on inguinal wound complications.
      2Single454/4542432111301, 4ND
      Costa Almeida (2014)
      • Costa Almeida C.E.P.
      • Reis L.
      • Carvalho L.
      • Costa Almeida C.M.
      Collagen implant with gentamicin sulphate reduces surgical site infection in vascular surgery: a prospective cohort study.
      2Single60/6030301301, 5Szilagyi
      Wübbeke (2020)
      • Wübbeke L.F.
      • Telgenkamp B.
      • van Boxtel T.
      • Bolt L.J.J.
      • Houthoofd S.
      • Vriens P.W.H.E.
      • et al.
      Gentamicin containing collagen implants and groin wound infections in vascular surgery: a prospective randomised controlled multicentre trial.
      1Multiple288/2881511371, 2421, 3, 5, 6, 9CDC
      Wound drain
      Healy (1989)
      • Healy D.A.
      • Keyser J.
      • Holcomb G.W.
      • Dean R.H.
      • Smith B.M.
      Prophylactic closed suction drainage of femoral wounds in patients undergoing vascular reconstruction.
      1Single50/10050/5050(501, 23041, 2, 3ND
      Dunlop (1990)
      • Dunlop M.G.
      • Fox J.N.
      • Clason A.E.
      • Stonebridge P.A.
      • Ruckley C.V.
      Vacuum drainage of groin wounds after vascular surgery.
      1Single99/127ND/65ND/621ND1, 2Defined by study conductors
      Youssef (2005)
      • Youssef F.
      • Jenkins M.P.
      • Dawson K.J.
      • Berger L.
      • Myint F.
      • Hamilton G.
      The value of suction wound drain after carotid and femoral artery surgery: A randomised trial using duplex assessment of the volume of post-operative haematoma.
      1Single73/106ND/49ND/57151, 2, 3, 4Defined by study conductors
      Platelet rich plasma
      Saratzis (2008)
      • Saratzis N.
      • Saratzis A.
      • Melas N.
      • Kiskinis D.
      Non-activated autologous platelet-rich plasma for the prevention of inguinal wound-related complications after endovascular repair of abdominal aortic aneurysms.
      2Single100/10050502301, 2, 3, 5ND
      Lawlor (2011)
      • Lawlor D.K.
      • Derose G.
      • Harris K.A.
      • Lovell M.B.
      • Novick T.V.
      • Forbes T.L.
      The role of platelet-rich plasma in inguinal wound healing in vascular surgery patients.
      1Single51/81ND/40ND/411, 2ND1ASEPSIS
      Subcuticular suture closure
      Murphy (1995)
      • Murphy P.G.
      • Tadros E.
      • Cross S.
      • Hehir D.
      • Burke P.E.
      • Kent P.
      • et al.
      Skin closure and the incidence of groin wound infection: a prospective study.
      1Single114/173ND/45ND/1281, 2141Defined by study conductors
      Nikulainen (2018)
      • Nikulainen V.
      • Helmiö P.
      • Hurme S.
      • Hakovirta H.
      Intra-dermal absorbable suture in the groin incision associated with less groin surgical site infections than trans-dermal sutures in vascular surgical patients.
      2Single256/330ND/262ND/681, 2301Szilagyi
      Fibrin glue
      Giovannacci (2002)
      • Giovannacci L.
      • Eugster T.
      • Stierli P.
      • Hess P.
      • Gürke L.
      Does fibrin glue reduce complications after femoral artery surgery? A randomised trial.
      1Single244/266ND/132ND/1341, 251, 2ND
      Silver alginate dressing
      Ozaki (2015)
      • Ozaki C.K.
      • Hamdan A.D.
      • Barshes N.R.
      • Wyers M.
      • Hevelone N.D.
      • Belkin M.
      • et al.
      Prospective, randomized, multi-institutional clinical trial of a silver alginate dressing to reduce lower extremity vascular surgery wound complications.
      1Multiple493/4932472461, 2301, 2, 3, 4NSQIP
      ciNPWT = closed incision negative pressure wound therapy; ND = not determined; CDC = Centers for Disease Control; ASEPSIS = A wound infection scoring system; NSQUIP = National surgical quality improvement program.
      1 = randomised control trial; 2 = observational
      1 = occlusive peripheral arterial disease; 2 = aneurysmal disease; 3 = trauma.
      1 = SSI; 2 = lymph leak/seroma; 3 = haematoma; 4 = wound dehiscence; 5 = length of stay in hospital; 6 = re-admission; 7 = re-operation; 8 = cost; 9 = allergic reaction.
      A total of 729 SSIs were reported, at a rate of 17.7% (per incision). Study characteristics are shown in Table 1. Table 2 shows bias assessments for RCTs. Observational studies had a median NOS of 5 (range 0 – 7) (Supplementary Material 1). A table demonstrating how GRADE strength of evidence was determined is shown in Supplementary Material 2. Funnel plots of meta-analyses are shown in Supplementary Material 3–7. Supplementary Material 8 gives details of the arterial pathology treated, and incision type (longitudinal vs. oblique). Supplementary Material 9 gives details of adjunct routine measures aimed at SSI reduction.
      Table 2Results of the randomised controlled trials bias assessment (Cochrane risk of bias tool) for randomised controlled trials evaluating wound adjuncts aimed at preventing groin wound surgical site infection following arterial surgery
      AuthorYearRandomisation processDeviation from intended interventionsMissing outcome dataMeasurement of the outcomeSelection of the reported resultOverall
      Dunlop
      • Dunlop M.G.
      • Fox J.N.
      • Clason A.E.
      • Stonebridge P.A.
      • Ruckley C.V.
      Vacuum drainage of groin wounds after vascular surgery.
      1990Low riskHigh riskHigh riskLow riskSome concernsHigh risk
      Engelhardt
      • Engelhardt M.
      • Rashad N.A.
      • Willy C.
      • Müller C.
      • Bauer C.
      • Debus S.
      • et al.
      Closed-incision negative pressure therapy to reduce groin wound infections in vascular surgery: a randomised controlled trial.
      2018Low riskLow riskLow riskSome concernsSome concernsSome concerns
      Gombert
      • Gombert A.
      • Babilon M.
      • Barbati M.E.
      • Keszei A.
      • von Trotha K.T.
      • Jalaie H.
      • et al.
      Closed incision negative pressure therapy reduces surgical site infections in vascular surgery: a prospective randomised trial (AIMS Trial).
      2018Low riskLow riskLow riskLow riskLow riskLow risk
      Hasselmann
      • Hasselmann J.
      • Björk J.
      • Svensson-Björk R.
      • Acosta S.
      Inguinal Vascular Surgical Wound Protection by Incisional Negative Pressure Wound Therapy: a randomized controlled trial – INVIPS Trial.
      2020Low riskLow riskSome concernsLow riskLow riskSome concerns
      Healy
      • Healy D.A.
      • Keyser J.
      • Holcomb G.W.
      • Dean R.H.
      • Smith B.M.
      Prophylactic closed suction drainage of femoral wounds in patients undergoing vascular reconstruction.
      1989Some concernsHigh riskHigh riskHigh riskSome concernsHigh risk
      Kwon
      • Kwon J.
      • Staley C.
      • McCullough M.
      • Goss S.
      • Arosemena M.
      • Abai B.
      • et al.
      A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications.
      2018Low riskLow riskLow riskLow riskLow riskLow risk
      Youseff
      • Youssef F.
      • Jenkins M.P.
      • Dawson K.J.
      • Berger L.
      • Myint F.
      • Hamilton G.
      The value of suction wound drain after carotid and femoral artery surgery: A randomised trial using duplex assessment of the volume of post-operative haematoma.
      2005Some concernsHigh riskLow riskHigh riskSome concernsHigh risk
      Wübbeke
      • Wübbeke L.F.
      • Telgenkamp B.
      • van Boxtel T.
      • Bolt L.J.J.
      • Houthoofd S.
      • Vriens P.W.H.E.
      • et al.
      Gentamicin containing collagen implants and groin wound infections in vascular surgery: a prospective randomised controlled multicentre trial.
      2020Low riskLow riskLow riskSome concernsLow riskSome concerns
      Sabat
      • Sabat J.
      • Tyagi S.
      • Srouji A.
      • Pechman D.
      • Gupta A.M.
      • Lucido D.
      • et al.
      IP123. Prophylactic negative-pressure therapy for femoral incision in vascular surgery: preliminary results of a prospective, randomized trial.
      2016Some concernsHigh riskHigh riskHigh riskSome concernsHigh risk
      Pleger
      • Pleger S.P.
      • Nink N.
      • Elzien M.
      • Kunold A.
      • Koshty A.
      • Böning A.
      Reduction of groin wound complications in vascular surgery patients using closed incision negative pressure therapy (ciNPT): a prospective, randomised, single-institution study.
      2017High riskLow riskLow riskSome concernsLow riskHigh risk
      Pitt
      • Pitt H.A.
      • Postier R.G.
      • MacGowan W.A.L.
      • Frank L.W.
      • Surmak A.J.
      • Sitzman J.V.
      • Bouchier-Hayes D.
      Prophylactic antibiotics in vascular surgery.
      1980Some concernsHigh riskLow riskLow riskSome concernsHigh risk
      Lee
      • Lee K.
      • Murphy P.B.
      • Ingves M.V.
      • Duncan A.
      • DeRose G.
      • Dubois L.
      • et al.
      Randomized clinical trial of negative pressure wound therapy for high-risk groin wounds in lower extremity revascularization.
      2017Low riskLow riskLow riskLow riskLow riskLow risk
      Lawlor
      • Lawlor D.K.
      • Derose G.
      • Harris K.A.
      • Lovell M.B.
      • Novick T.V.
      • Forbes T.L.
      The role of platelet-rich plasma in inguinal wound healing in vascular surgery patients.
      2011Low riskLow riskLow riskLow riskSome concernsSome concerns
      Giovannacci
      • Giovannacci L.
      • Eugster T.
      • Stierli P.
      • Hess P.
      • Gürke L.
      Does fibrin glue reduce complications after femoral artery surgery? A randomised trial.
      2002Some concernsLow riskHigh riskHigh riskSome concernsHigh risk
      Ozaki
      • Ozaki C.K.
      • Hamdan A.D.
      • Barshes N.R.
      • Wyers M.
      • Hevelone N.D.
      • Belkin M.
      • et al.
      Prospective, randomized, multi-institutional clinical trial of a silver alginate dressing to reduce lower extremity vascular surgery wound complications.
      2015Some concernsLow riskLow riskHigh riskLow riskHigh risk
      Murphy
      • Murphy P.G.
      • Tadros E.
      • Cross S.
      • Hehir D.
      • Burke P.E.
      • Kent P.
      • et al.
      Skin closure and the incidence of groin wound infection: a prospective study.
      1995Some concernsHigh riskHigh riskHigh riskSome concernsHigh risk

      Outcome data

      Closed incision negative pressure wound therapy

      Eleven studies, including 1 347 groin incisions (1 260 patients) evaluated ciNPWT vs. standard care (eight RCTs, three observational studies) (Table 3).
      • Karl T.
      • Woeste S.
      Vermeidung von inguinalen Wundheilungsstörungen in der Gefäßchirurgie: Ergebnisse der Anwendung eines epidermalen Unterdrucksystems (PREVENATM).
      • Matatov T.
      • Reddy K.N.
      • Doucet L.D.
      • Zhao C.X.
      • Zhang W.W.
      Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients.
      • Hasselmann J.
      • Björk J.
      • Svensson-Björk R.
      • Acosta S.
      Inguinal Vascular Surgical Wound Protection by Incisional Negative Pressure Wound Therapy: a randomized controlled trial – INVIPS Trial.
      • Koetje J.H.
      • Ottink K.D.
      • Feenstra I.
      • Fritschy W.M.
      Negative pressure incision management system in the prevention of groin wound infection in vascular surgery patients.
      • Sabat J.
      • Tyagi S.
      • Srouji A.
      • Pechman D.
      • Gupta A.M.
      • Lucido D.
      • et al.
      IP123. Prophylactic negative-pressure therapy for femoral incision in vascular surgery: preliminary results of a prospective, randomized trial.
      • Fleming C.A.
      • Kuteva M.
      • O’Hanlon K.
      • O’Brien G.
      • McGreal G.
      Routine use of PICO dressings may reduce overall groin wound complication rates following peripheral vascular surgery.
      • Lee K.
      • Murphy P.B.
      • Ingves M.V.
      • Duncan A.
      • DeRose G.
      • Dubois L.
      • et al.
      Randomized clinical trial of negative pressure wound therapy for high-risk groin wounds in lower extremity revascularization.
      • Pleger S.P.
      • Nink N.
      • Elzien M.
      • Kunold A.
      • Koshty A.
      • Böning A.
      Reduction of groin wound complications in vascular surgery patients using closed incision negative pressure therapy (ciNPT): a prospective, randomised, single-institution study.
      • Engelhardt M.
      • Rashad N.A.
      • Willy C.
      • Müller C.
      • Bauer C.
      • Debus S.
      • et al.
      Closed-incision negative pressure therapy to reduce groin wound infections in vascular surgery: a randomised controlled trial.
      • Gombert A.
      • Babilon M.
      • Barbati M.E.
      • Keszei A.
      • von Trotha K.T.
      • Jalaie H.
      • et al.
      Closed incision negative pressure therapy reduces surgical site infections in vascular surgery: a prospective randomised trial (AIMS Trial).
      • Kwon J.
      • Staley C.
      • McCullough M.
      • Goss S.
      • Arosemena M.
      • Abai B.
      • et al.
      A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications.
      The overall reported SSI rate was 20.6% (per incision) at a weighted mean follow up of 75.7 days. Heterogeneity was low (I2 = 24%). Meta-analysis demonstrated a significant overall effect in favour of ciNPWT for reducing SSIs (OR 0.34, 95% CI 0.23 – 0.51, p < .001; GRADE strength of evidence: moderate, Fig. 2). On sensitivity analyses, this effect was almost unchanged when RCTs (n = 8) were considered alone, and when studies reporting less than 90 day follow up (n = 7) were pooled. ciNPWT remained significant when evaluating both superficial and deep SSIs (n = 7), although the effect was greater for reduction in deep SSIs (OR 0.29, 95% CI 0.17 – 0.50) compared with superficial (OR 0.40, 95% CI 0.26 – 0.61). The overall effect was significant in favour of ciNPWT in reducing both superficial and deep SSIs when only RCTs (n = 5) were included, but when observational studies (n = 2) were considered alone the overall effect was only significant for ciNPWT in reducing deep SSIs (Fig. 3). Similarly, ciNPWT was significant when evaluating studies reporting SSI rates both above (OR 0.26, 95% CI 0.17 – 0.39) and below (OR 0.54, 95% CI 0.31 – 0.92) the median reported SSI rate (15.13%), although the effect was greater in studies reporting a higher SSI rate. Significance for an effect of ciNPWT on SSIs was lost when observational studies (n = 3) were considered in isolation, or studies with follow up of greater than 90 days (n = 4) were considered alone.
      Table 3Summary of treatment/control surgical site infection (SSI) rates, heterogeneity, overall treatment effect results, and GRADE score strength of evidence for meta-analyses of studies evaluating wound adjuncts aimed at preventing groin wound surgical site infection following arterial surgery
      Wound adjunctOutcomeStudies – nTreatmentStandard careOR/SMD95% CIpI2

      – %
      GRADE score
      Events/Weighted meanTotalEvents/Weighted meanTotal
      ciNPWTSSI (all)11636551656890.340.23–0.51<.00124Moderate
      ciNPWTSSI (follow up <90 days)7414541214800.300.20–0.44<.0010Moderate
      ciNPWTSSI (follow up >90 days)422201442090.500.21–1.19.1251Moderate
      ciNPWTSSI (superficial)732449764820.400.26–0.61<.0016Moderate
      ciNPWTSSI (deep)717449594820.290.17–0.50<.00141Moderate
      ciNPWTSSI (≤median)625305443170.540.31–0.92.0200Moderate
      ciNPWTSSI (>median)5383501213720.260.17–0.39<.0011Moderate
      ciNPWTLymph complication/seroma418268292890.650.33–1.28.211Moderate
      ciNPWTWound dehiscence417240122511.540.70–3.38.280Moderate
      ciNPWTHaematoma43268162890.320.10–1.03.0600Moderate
      ciNPWTRe-operation411248272600.440.19–1.04.06012Moderate
      ciNPWTRe-admission319190191890.930.28–3.05.9058Low
      ciNPWTLOS47.82888.1279–0.12−0.41– −0.17.4266Low
      Local antibioticsSSI453478904400.390.16–0.94.04057Moderate
      Local antibioticsSSI (superficial)228273442710.530.32–0.89.0200Low
      Local antibioticsSSI (deep)214273152710.870.41–1.84.710Low
      Local antibioticsLOS25.91817.2167–0.62–1.56–0.32.2090Low
      Wound drainSSI369164691690.840.37–1.91.680Low
      Platelet rich plasmaSSI289016910.460.19–1.13.09036Low
      Intra-dermal sutureSSI225307211960.330.17–0.65.0010Low
      ciNPWT = closed incision negative pressure wound therapy; OR odds ratio; SMD = standard mean difference; CI = confidence interval; LOS = length of hospital stay.
      Figure 2
      Figure 2Forest plot for surgical site infection rates comparing closed incision Negative Pressure Wound Therapy (ciNPWT) with standard care in groin incisions for arterial exposure in randomised controlled studies (RCTs) and observational studies. M-H = Mantel–Haenszel; CI confidence interval.
      Figure 3
      Figure 3Forest plot for superficial surgical site infection (SSI) and deep SSI rates comparing closed incision negative pressure wound therapy (ciNPWT) with standard care in groin incisions for arterial exposure in randomised controlled studies (RCTs) and observational studies. M-H = Mantel–Haenszel; CI confidence interval.
      Six secondary outcomes were subjected to meta-analysis (lymph complication or seroma, wound dehiscence, haematoma, re-operation, re-admission, and LOS). No significant differences in any of these outcomes were noted (Table 3). Two studies analysed cost, although it was not possible to pool costing data for meta-analysis. A non-significant trend toward lower cost in the ciNPWT group was observed in two studies.
      • Fleming C.A.
      • Kuteva M.
      • O’Hanlon K.
      • O’Brien G.
      • McGreal G.
      Routine use of PICO dressings may reduce overall groin wound complication rates following peripheral vascular surgery.
      ,
      • Kwon J.
      • Staley C.
      • McCullough M.
      • Goss S.
      • Arosemena M.
      • Abai B.
      • et al.
      A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications.

      Local antibiotics

      Four studies including 1 007 groin incisions (1 007 patients) compared local antibiotics placed within the surgical site just prior to wound closure, with standard care (two RCTs, two observational).
      • Pitt H.A.
      • Postier R.G.
      • MacGowan W.A.L.
      • Frank L.W.
      • Surmak A.J.
      • Sitzman J.V.
      • Bouchier-Hayes D.
      Prophylactic antibiotics in vascular surgery.
      • Mohammed S.
      • Pisimisis G.T.
      • Daram S.P.
      • Bechara C.F.
      • Barshes N.R.
      • Lin P.H.
      • et al.
      Impact of intraoperative administration of local vancomycin on inguinal wound complications.
      • Costa Almeida C.E.P.
      • Reis L.
      • Carvalho L.
      • Costa Almeida C.M.
      Collagen implant with gentamicin sulphate reduces surgical site infection in vascular surgery: a prospective cohort study.
      • Wübbeke L.F.
      • Telgenkamp B.
      • van Boxtel T.
      • Bolt L.J.J.
      • Houthoofd S.
      • Vriens P.W.H.E.
      • et al.
      Gentamicin containing collagen implants and groin wound infections in vascular surgery: a prospective randomised controlled multicentre trial.
      The local antibiotics evaluated were gentamicin delivered in a collagen implant (n = 2; one RCT [Garacol®],
      • Wübbeke L.F.
      • Telgenkamp B.
      • van Boxtel T.
      • Bolt L.J.J.
      • Houthoofd S.
      • Vriens P.W.H.E.
      • et al.
      Gentamicin containing collagen implants and groin wound infections in vascular surgery: a prospective randomised controlled multicentre trial.
      and one observational [Collatamp®]
      • Costa Almeida C.E.P.
      • Reis L.
      • Carvalho L.
      • Costa Almeida C.M.
      Collagen implant with gentamicin sulphate reduces surgical site infection in vascular surgery: a prospective cohort study.
      ), vancomycin powder and irrigation (n = 1),
      • Mohammed S.
      • Pisimisis G.T.
      • Daram S.P.
      • Bechara C.F.
      • Barshes N.R.
      • Lin P.H.
      • et al.
      Impact of intraoperative administration of local vancomycin on inguinal wound complications.
      and cephradine solution (n = 1).
      • Pitt H.A.
      • Postier R.G.
      • MacGowan W.A.L.
      • Frank L.W.
      • Surmak A.J.
      • Sitzman J.V.
      • Bouchier-Hayes D.
      Prophylactic antibiotics in vascular surgery.
      Systemic antibiotics were delivered to both treatment and control groups in all studies. Heterogeneity was low (I2 = 40%). Meta-analysis demonstrated no significant difference in SSI rate (OR 0.60, 95% CI 0.30 – 1.21, p = .15, GRADE strength of evidence: moderate, Fig. 4). Sensitivity analysis using a different comparison in one multi-arm RCT (local cephradine vs. no antibiotic)
      • Pitt H.A.
      • Postier R.G.
      • MacGowan W.A.L.
      • Frank L.W.
      • Surmak A.J.
      • Sitzman J.V.
      • Bouchier-Hayes D.
      Prophylactic antibiotics in vascular surgery.
      demonstrated a significant overall effect in favour of local antibiotics (OR 0.39, 95% CI 0.16 – 0.94, p = .040). Further sensitivity analyses demonstrated a significant overall effect in favour of local antibiotics for preventing superficial SSI (OR 0.53, 95% CI 0.32 – 0.89, p = .020, I2 = 0%, GRADE strength of evidence: low), but not for deep SSI (OR 0.87, 95% CI 0.41 – 1.84, p = .71, I2 = 0%, GRADE strength of evidence: low). Two studies reported LOS, with no significant difference between the two groups (SMD = –0.62, 95% CI –1.56 – 0.32, p = .20, GRADE quality of evidence: low).
      Figure 4
      Figure 4Forest plot for surgical site infection rates comparing local antibiotics with standard care in groin incisions for arterial exposure. M-H = Mantel–Haenszel; CI confidence interval.

      Other interventions

      Three RCTs studied placement of a wound drain (closed system on suction) vs. standard care in 333 groin incisions (222 patients).
      • Healy D.A.
      • Keyser J.
      • Holcomb G.W.
      • Dean R.H.
      • Smith B.M.
      Prophylactic closed suction drainage of femoral wounds in patients undergoing vascular reconstruction.
      • Dunlop M.G.
      • Fox J.N.
      • Clason A.E.
      • Stonebridge P.A.
      • Ruckley C.V.
      Vacuum drainage of groin wounds after vascular surgery.
      • Youssef F.
      • Jenkins M.P.
      • Dawson K.J.
      • Berger L.
      • Myint F.
      • Hamilton G.
      The value of suction wound drain after carotid and femoral artery surgery: A randomised trial using duplex assessment of the volume of post-operative haematoma.
      Meta-analysis demonstrated no significant difference in SSI rate (OR 0.84, 95% CI 0.37 – 1.91, p = .68, I2 = 0%, GRADE strength of evidence: low). Similarly, there was no significant difference in the rates of superficial SSIs, deep SSIs, re-intervention to manage SSI, lymph leak, or haematoma in these studies. These secondary outcomes could not be subjected to meta-analyses as each was reported by single studies.
      Two studies including 181 groin incisions (151 patients) evaluated instilling wounds with platelet rich plasma (PRP) prior to closure vs. standard care (one RCT, one observational).
      • Saratzis N.
      • Saratzis A.
      • Melas N.
      • Kiskinis D.
      Non-activated autologous platelet-rich plasma for the prevention of inguinal wound-related complications after endovascular repair of abdominal aortic aneurysms.
      ,
      • Lawlor D.K.
      • Derose G.
      • Harris K.A.
      • Lovell M.B.
      • Novick T.V.
      • Forbes T.L.
      The role of platelet-rich plasma in inguinal wound healing in vascular surgery patients.
      Meta-analysis demonstrated a non-significant trend towards a lower SSI rate in the PRP group (OR 0.46, 95% CI 0.19 – 1.13, p = .090, I2 = 36%, GRADE strength of evidence: low). In one study SSI rates were lower for both superficial (2/50 vs. 9/50) and deep (0/50 vs. 1/50) SSIs.
      Two studies including 503 groin incisions (370 patients) compared subcuticular suture closure vs. either transdermal sutures or skin clips (one RCT, one observational).
      • Nikulainen V.
      • Helmiö P.
      • Hurme S.
      • Hakovirta H.
      Intra-dermal absorbable suture in the groin incision associated with less groin surgical site infections than trans-dermal sutures in vascular surgical patients.
      ,
      • Murphy P.G.
      • Tadros E.
      • Cross S.
      • Hehir D.
      • Burke P.E.
      • Kent P.
      • et al.
      Skin closure and the incidence of groin wound infection: a prospective study.
      Heterogeneity was low (I2 = 36%). Meta-analysis showed a significantly lower SSI rate in the subcuticular suture group (OR 0.33, 95% CI 0.17 – 0.65, p = .001, GRADE strength of evidence: low).
      One RCT compared the application of fibrin glue to the wound prior to closure vs. standard care in 266 groin incisions (244 patients).
      • Giovannacci L.
      • Eugster T.
      • Stierli P.
      • Hess P.
      • Gürke L.
      Does fibrin glue reduce complications after femoral artery surgery? A randomised trial.
      There was no significant difference in all SSI rate between the two groups (4/132 vs. 6/134, p value “not significant”), superficial SSIs (4/132 vs. 2/134, no p value), or deep SSIs (0/132 vs. 4/134, no p value). There was a significantly reduced lymph complication in the fibrin glue group (13/132 vs. 26/134, p = .030).
      One RCT evaluated the use of a silver alginate dressing vs. standard dressing in 493 groin incisions (493 patients).
      • Ozaki C.K.
      • Hamdan A.D.
      • Barshes N.R.
      • Wyers M.
      • Hevelone N.D.
      • Belkin M.
      • et al.
      Prospective, randomized, multi-institutional clinical trial of a silver alginate dressing to reduce lower extremity vascular surgery wound complications.
      There was no significant difference in SSI rates between the two groups (42/247 vs. 38/246, p = .64), superficial SSIs (32/247 vs. 29/246, no p value), or deep SSIs (10/247 vs. 9/246, no p value).

      Discussion

      This systematic review identified 24 articles reporting data on 4 130 groin incisions. Eleven studies investigated ciNPWT vs. standard care, with meta-analysis of 1 260 patients demonstrating a significant overall effect in favour of ciNPWT, corresponding to a two thirds relative reduction in the odds of SSI development. This effect was sustained when performing sensitivity analyses including RCTs only (n = 8), studies with < 90 days of follow up only (n = 7), and in those reporting superficial and deep (n = 7) SSI rates, although it was lost with observational studies only (n = 3), studies with at least 90 days of follow up only (n = 4), and observational studies evaluating superficial SSI rates only (n = 2). ciNPWT demonstrated more benefit in reducing SSI when considering studies with an overall SSI rate above the median, suggesting that patients who are at a higher risk of SSI may derive greater benefit. These findings add greater detail to the previously conducted meta-analyses on this topic;
      • Sexton F.
      • Healy D.
      • Keelan S.
      • Alazzawi M.
      • Naughton P.
      A systematic review and meta-analysis comparing the effectiveness of negative-pressure wound therapy to standard therapy in the prevention of complications after vascular surgery.
      • Gombert A.
      • Dillavou E.
      • D’Agostino R.
      • Griffin L.
      • Robertson J.M.
      • Eells M.
      A systematic review and meta-analysis of randomized controlled trials for the reduction of surgical site infection in closed incision management versus standard of care dressings over closed vascular groin incisions.
      • Antoniou G.A.
      • Onwuka C.C.
      • Antoniou S.A.
      • Russell D.
      Meta-analysis and trial sequential analysis of prophylactic negative pressure therapy for groin wounds in vascular surgery.
      a greater number of studies (both RCTs and observational studies), were included and sensitivity and GRADE analyses were performed. These results are consistent with prophylactic ciNPWT use in multiple other surgical specialties, with favourable results.
      • Shiroky J.
      • Lillie E.
      • Muaddi H.
      • Sevigny M.
      • Choi W.J.
      • Karanicolas P.J.
      The impact of negative pressure wound therapy for closed surgical incisions on surgical site infection: A systematic review and meta-analysis.
      ,
      • Cagney D.
      • Simmons L.
      • O’Leary D.P.
      • Corrigan M.
      • Kelly L.
      • O’Sullivan M.J.
      • et al.
      The Efficacy of prophylactic negative pressure wound therapy for closed incisions in breast surgery: a systematic review and meta-analysis.
      Four studies evaluated local antibiotics placed within the surgical wound just prior to closure. The primary analyses suggest that local antibiotics do not prevent overall SSI rates; however, sensitivity analysis suggested they may prevent superficial SSIs. Heterogeneity was significant among the studies and the GRADE strength of evidence was low. The variability in antibiotic agents used and the method of their delivery within the included studies are a significant limitation. The evidence for prophylactic application of local antibiotics to wounds (of any kind) in other surgical specialties is conflicting, with variability in their efficacy between specialties and procedure types.
      • Xie L.
      • Zhu J.
      • Yang M.
      • Yang C.
      • Luo S.
      • Xie Y.
      • et al.
      Effect of Intra-wound Vancomycin for Spinal Surgery: A Systematic Review and Meta-analysis.
      ,
      • Nelson R.L.
      • Kravets A.
      • Khateeb R.
      • Raza M.
      • Siddiqui M.
      • Taha I.
      • et al.
      Topical antimicrobial prophylaxis in colorectal surgery for the prevention of surgical wound infection: a systematic review and meta-analysis.
      Currently, their routine use in vascular groin wounds cannot be recommended.
      Use of subcuticular suture closure resulted in lower SSI rates when compared with transdermal sutures or skin clips (GRADE strength of evidence: low). This contrasts with a recent Cochrane Review of subcuticular sutures in non-obstetric surgery,
      • Goto S.
      • Sakamoto T.
      • Ganeko R.
      • Hida K.
      • Furukawa T.A.
      • Sakai Y.
      Subcuticular sutures for skin closure in non-obstetric surgery.
      which found no difference in SSI rates. Other adjuncts evaluated in the study (including placement of wound drains, wound instillation with PRP, fibrin glue and silver alginate dressing) showed no clear evidence of SSI reduction. These findings generally correspond with results from non-groin wound surgery, which have broadly failed to demonstrate evidence of efficacy of these interventions in reducing SSIs.
      • Weldrick C.
      • Bashar K.
      • O’Sullivan T.A.
      • Gillis E.
      • Clarke Moloney M.
      • Tang T.Y.
      • et al.
      A comparison of fibrin sealant versus standard closure in the reduction of postoperative morbidity after groin dissection: a systematic review and meta-analysis.
      • Samraj K.
      • Gurusamy K.S.
      Wound drains following thyroid surgery.
      • Sangiovanni T.P.
      • Kiebzak G.M.
      prospective randomized evaluation of intraoperative application of autologous platelet-rich plasma on surgical site infection or delayed wound healing.
      • Li H.Z.
      • Chen J.X.
      • Zheng Y.
      • Zhu X.N.
      • Zhang L.
      Silver-containing dressing for surgical site infection in clean and clean-contaminated operations: a systematic review and meta-analysis of randomized controlled trials.
      Reporting of secondary outcomes (lymph complications or seroma, wound dehiscence, haematoma, LOS, re-operation, re-admission, and cost) was variable and the meta-analyses of these included no greater than four studies reporting on each specified outcome. None of the wound adjuncts evaluated demonstrated a significant overall effect on secondary outcomes.
      This review permits direct comparisons of level of evidence of the few interventions which have been studied and has highlighted that several unanswered questions remain when seeking to prevent vascular groin incision SSIs. A number of interventions – including antimicrobial triclosan coated sutures,
      • Henriksen N.A.
      • Deerenberg E.B.
      • Venclauskas L.
      • Fortelny R.H.
      • Garcia-Alamino J.M.
      • Miserez M.
      • et al.
      Triclosan-coated sutures and surgical site infection in abdominal surgery: the TRISTAN review, meta-analysis and trial sequential analysis.
      cyanoacrylate glue,
      • Chambers A.
      • Scarci M.
      Is skin closure with cyanoacrylate glue effective for the prevention of sternal wound infections?.
      and the antimicrobial dialkylcarbamoyl chloride (DACC) dressings
      • Totty J.P.
      • Bua N.
      • Smith G.E.
      • Harwood A.E.
      • Carradice D.
      • Wallace T.
      • et al.
      Dialkylcarbamoyl chloride (DACC)-coated dressings in the management and prevention of wound infection: a systematic review.
      – have not been assessed in the context of groin wounds, despite evidence from other surgical fields that these interventions reduce SSI rates.
      This systematic review and meta-analysis provides a contemporary update on an important issue for vascular surgeons and their patients. There are, however, some limitations to the study. The included studies span 40 years and therefore encompass significant changes in surgical practice, which invariably introduces bias. Many studies were not contemporaneous and may not therefore account for changes in microbial characteristics, patient factors, operative technique, and theatre environment over time. Included studies were mostly small and potentially underpowered. It was not possible to meta-analyse the results of cost effectiveness analysis for ciNPWT, limiting the ability to make better informed recommendations. The studies examining local antibiotics are few in number and inhomogeneous in terms of the antibiotic agent used and the mode of delivery, meaning that these results should be interpreted with caution. Some heterogeneity was demonstrated in the type of operative intervention performed between studies (occlusive disease, aneurysmal disease, or trauma) and the type of incision used (longitudinal vs. oblique), which is a limitation of this study; additionally, these groups could not be assessed separately to identify whether interventions were more effective in certain cohorts. Other interventions aimed at reducing SSI (e.g., skin preparation, temperature, and glycaemic control) were infrequently reported and are a potential source of bias. There are also limitations regarding trial methodology, such as heterogeneity of blinding, allocation and outcome reporting. There is a wide variation in the definitions of SSI used, many of which are non-standard. The studies also varied considerably with regards to follow up duration, and the sensitivity analysis of ciNPWT studies demonstrate this to be a relevant limitation of the evidence. As a result of these factors, the evidence contributing to meta-analyses within this systematic review was determined to be only low/moderate based on GRADE scoring.
      For current practice, ciNPWT has reasonable evidence demonstrating efficacy which is further maintained on most sensitivity analyses. Data would suggest that higher risk cohorts of patients derive a greater benefit than lower risk cohorts and, given the scant cost effectiveness data, it would be reasonable to selectively use them in “high risk” groins. The analyses of local antibiotic data suggest that there is no effect on SSIs overall and they should not be recommended for routine use; the current results suggest they may have efficacy in reducing superficial SSIs. The results from limited data suggest subcuticular suture use reduces SSIs and this should be used preferentially. Wound drains are not recommended for the prophylactic reduction of SSIs. The other interventions included in this study lack good data and, on this basis, should not be suggested for use in groin SSI prevention.

      Conclusion

      This systematic review and meta-analysis, comprising over 3 000 groin incisions and spanning four decades of research, has demonstrated that ciNPWT may have a role in reducing the rate of SSIs in vascular groin wounds. Subcuticular sutures also appear to reduce SSI rates. Local antibiotics do not appear to reduce SSIs in vascular groin wounds however the quantity and quality of evidence is poor. Other adjuncts, such as placement of wound drains, use of PRP, and use of specialised dressings, have no evidence of efficacy. Given the recognised association between vascular SSIs and adverse clinical outcomes, this review highlights the need for high quality, multicentre prospective randomised controlled trials to evaluate the clinical and cost effectiveness of wound adjuncts in preventing SSIs in vascular groin wounds.

      Conflict of interest

      None.

      Funding

      None.

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      Linked Article

      • The Groin: A Vascular Surgeon's Achilles Heel
        European Journal of Vascular and Endovascular SurgeryVol. 61Issue 4
        • Preview
          Surgical site infections (SSI) affecting the groin and femoral vessels, which are common access sites and target vessels of vascular surgical procedures, are of clinical and economic relevance.1 In their systematic review and meta-analysis, Gwilym et al. assessed different interventions and adjuncts delivered immediately before, during, or after skin closure, to prevent SSI in patients undergoing arterial interventions involving a groin incision.2 In their well conducted and methodologically appropriate analysis, the authors summarised relevant options for prevention of SSI following groin incision.
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