Intradermal Suture Versus Stapling for Groin Skin Closure in Vascular Surgery (VASC-INF Trial)
NCT ID: NCT05434182
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
225 participants
INTERVENTIONAL
2022-03-04
2025-03-14
Brief Summary
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A 2021 meta-analysis on groin SSI prevention strategies in arterial surgeries reported that using intradermal sutures could be associated with a lower SSI rate. The published results from a single-center retrospective study comparing SSI rates before and after implementing an SSI prevention protocol also suggest better outcomes with intradermal suturing.
This study aims to assess the SSI incidences of both skin closure techniques in vascular surgery patients undergoing femoral artery approach through a perpendicular groin skin incision.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intradermal Suture Group
Vascular surgery patients undergoing a femoral approach surgery and randomized to this group will have their skin closed with an intradermal suture using Monosyn® (Braun®) 4/0 absorbable monofilament.
Intradermal Suture
Skin closure with an intradermal suture using Monosyn® (Braun®) 4/0 absorbable monofilament.
Metallic Staples
Vascular surgery patients undergoing a femoral approach surgery and randomized to this group will have their skin closed with metallic stapling using Visistat® (Weck®) 35W skin stapler.
Metallic Staples
Skin closure with metallic stapling using Visistat® (Weck®) 35W skin stapler.
Interventions
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Intradermal Suture
Skin closure with an intradermal suture using Monosyn® (Braun®) 4/0 absorbable monofilament.
Metallic Staples
Skin closure with metallic stapling using Visistat® (Weck®) 35W skin stapler.
Eligibility Criteria
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Inclusion Criteria
* With a scheduled surgery for one of the following indications:
* Femoropopliteal Bypass
* Femorodistal Bypass
* Aortobifemoral Bypass
* Axillofemoral or Axillobifemoral Bypass
* Femorofemoral Bypass
* Femoral Endarterectomy
* Femoral approach for exclusion of an aortic aneurysm
* Surgical procedure with an incision perpendicular to the inguinal fold
* Patients who undergo both unilateral and bilateral surgical approaches \*
\*Note: We will consider one patient as one intervention (i.e., bilateral approaches will be quantified as one single inguinal surgical approach). In the case of bilateral procedures, the same closure technique will be used for both sides.
* Patients who sign the written informed consent
Exclusion Criteria
* Femoral approach carried out in a surgical emergency setting
* Femoral approach performed due to a femoral pseudoaneurysm
* A surgical procedure performed with a transverse/oblique incision to the groin
* A patient who withdraws consent for participating in the trial
18 Years
ALL
No
Sponsors
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Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Albert Gonzalez-Sagredo
Surgeon at the Vascular Surgery and Angiology Department
Principal Investigators
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Elena Iborra, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge - Angiology and Vascular Surgery Department
Locations
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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References
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Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. doi: 10.3201/eid0902.020232.
Chakfe N, Diener H, Lejay A, Assadian O, Berard X, Caillon J, Fourneau I, Glaudemans AWJM, Koncar I, Lindholt J, Melissano G, Saleem BR, Senneville E, Slart RHJA, Szeberin Z, Venermo M, Vermassen F, Wyss TR, Esvs Guidelines Committee, de Borst GJ, Bastos Goncalves F, Kakkos SK, Kolh P, Tulamo R, Vega de Ceniga M, Document Reviewers, von Allmen RS, van den Berg JC, Debus ES, Koelemay MJW, Linares-Palomino JP, Moneta GL, Ricco JB, Wanhainen A. Editor's Choice - European Society for Vascular Surgery (ESVS) 2020 Clinical Practice Guidelines on the Management of Vascular Graft and Endograft Infections. Eur J Vasc Endovasc Surg. 2020 Mar;59(3):339-384. doi: 10.1016/j.ejvs.2019.10.016. Epub 2020 Feb 5. No abstract available.
Groin wound Infection after Vascular Exposure (GIVE) Study Group. Groin wound infection after vascular exposure (GIVE) multicentre cohort study. Int Wound J. 2021 Apr;18(2):164-175. doi: 10.1111/iwj.13508. Epub 2020 Nov 25.
Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999 Nov;20(11):725-30. doi: 10.1086/501572.
Gwilym BL, Dovell G, Dattani N, Ambler GK, Shalhoub J, Forsythe RO, Benson RA, Nandhra S, Preece R, Onida S, Hitchman L, Coughlin P, Saratzis A, Bosanquet DC. Editor's Choice - Systematic Review and Meta-Analysis of Wound Adjuncts for the Prevention of Groin Wound Surgical Site Infection in Arterial Surgery. Eur J Vasc Endovasc Surg. 2021 Apr;61(4):636-646. doi: 10.1016/j.ejvs.2020.11.053. Epub 2021 Jan 7.
Nikulainen V, Helmio 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. Surg Infect (Larchmt). 2019 Jan;20(1):45-48. doi: 10.1089/sur.2018.202. Epub 2018 Oct 6.
Parizh D, Ascher E, Raza Rizvi SA, Hingorani A, Amaturo M, Johnson E. Quality improvement initiative: Preventative Surgical Site Infection Protocol in Vascular Surgery. Vascular. 2018 Feb;26(1):47-53. doi: 10.1177/1708538117719155. Epub 2017 Jul 14.
Engin C, Posacioglu H, Ayik F, Apaydin AZ. Management of vascular infection in the groin. Tex Heart Inst J. 2005;32(4):529-34.
Yashar JJ, Weyman AK, Burnard RJ, Yashar J. Survival and limb salvage in patients with infected arterial prostheses. Am J Surg. 1978 Apr;135(4):499-504. doi: 10.1016/0002-9610(78)90027-2.
Pleger SP, Nink N, Elzien M, Kunold A, Koshty A, Boning A. Reduction of groin wound complications in vascular surgery patients using closed incision negative pressure therapy (ciNPT): a prospective, randomised, single-institution study. Int Wound J. 2018 Feb;15(1):75-83. doi: 10.1111/iwj.12836. Epub 2017 Oct 25.
Antonios VS, Noel AA, Steckelberg JM, Wilson WR, Mandrekar JN, Harmsen WS, Baddour LM. Prosthetic vascular graft infection: a risk factor analysis using a case-control study. J Infect. 2006 Jul;53(1):49-55. doi: 10.1016/j.jinf.2005.10.004. Epub 2005 Nov 28.
Oderich GS, Panneton JM. Aortic graft infection. What have we learned during the last decades? Acta Chir Belg. 2002 Feb;102(1):7-13. doi: 10.1080/00015458.2002.11679254. No abstract available.
Siracuse JJ, Nandivada P, Giles KA, Hamdan AD, Wyers MC, Chaikof EL, Pomposelli FB, Schermerhorn ML. Prosthetic graft infections involving the femoral artery. J Vasc Surg. 2013 Mar;57(3):700-5. doi: 10.1016/j.jvs.2012.09.049. Epub 2013 Jan 9.
Wiseman JT, Fernandes-Taylor S, Barnes ML, Saunders RS, Saha S, Havlena J, Rathouz PJ, Kent KC. Predictors of surgical site infection after hospital discharge in patients undergoing major vascular surgery. J Vasc Surg. 2015 Oct;62(4):1023-1031.e5. doi: 10.1016/j.jvs.2015.04.453. Epub 2015 Jul 3.
Leekha S, Lahr BD, Thompson RL, Sampathkumar P, Duncan AA, Orenstein R. Preoperative risk prediction of surgical site infection requiring hospitalization or reoperation in patients undergoing vascular surgery. J Vasc Surg. 2016 Jul;64(1):177-84. doi: 10.1016/j.jvs.2016.01.029. Epub 2016 Feb 27.
Pounds LL, Montes-Walters M, Mayhall CG, Falk PS, Sanderson E, Hunter GC, Killewich LA. A changing pattern of infection after major vascular reconstructions. Vasc Endovascular Surg. 2005 Nov-Dec;39(6):511-7.
Gurusamy KS, Toon CD, Allen VB, Davidson BR. Continuous versus interrupted skin sutures for non-obstetric surgery. Cochrane Database Syst Rev. 2014 Feb 14;2014(2):CD010365. doi: 10.1002/14651858.CD010365.pub2.
Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10:CD015022. doi: 10.1002/14651858.CD015022.pub2.
Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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VASC-INF-2021-01
Identifier Type: -
Identifier Source: org_study_id
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