Intradermal Suture Versus Stapling for Groin Skin Closure in Vascular Surgery (VASC-INF Trial)

NCT05434182 | Completed DMC

• 1 other identifier: VASC-INF-2021-01
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical site infection (SSI) is one of the most frequent and fearsome complications in vascular surgery due to its high morbidity and mortality. In addition, SSI is one of the factors related to the development of prosthetic infection. Consequently, it represents a significant increase in hospital stay and healthcare costs. 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.

Conditions

Surgical Site Infection

Keywords

Femoral approach; Intradermal suture; Metallic staples; Surgical Site Infection; Groin

Outcome Measures

Primary Outcomes (1)

• Number (percentage) of patients who present a femoral approach SSI* -(superficial and/or deep) up to 28 (±2) after surgery.

  According to the National Healthcare Safety Network (NHSN) Classification

  28 (±2) days after surgery

Secondary Outcomes (13)

• Number (percentage) of patients with other surgical wound complications up to 28 (±2) days after surgery.

  28 (±2) days after surgery

• Number (percentage) of patients who develop sepsis up to 28 (±2) days after surgery

  28 (±2) days after surgery

• Number (percentage) of patients with SSI who develop sepsis up to 28 (±2) days after surgery.

  28 (±2) days after surgery

• Time of prophylactic antibiotic administration

  28 (±2) days after surgery

• Types of microorganisms isolated from skin microbiological culture, subcutaneous tissue sample culture, and SSI secretion culture up to 28 (±2) days after surgery.

  28 (±2) days after surgery

Study Arms (2)

Intradermal Suture Group

EXPERIMENTAL

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.

Procedure: Intradermal Suture

Metallic Staples

ACTIVE COMPARATOR

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.

Procedure: Metallic Staples

Interventions

Intradermal Suture PROCEDURE

Skin closure with an intradermal suture using Monosyn® (Braun®) 4/0 absorbable monofilament.

Intradermal Suture Group

Metallic Staples PROCEDURE

Skin closure with metallic stapling using Visistat® (Weck®) 35W skin stapler.

Metallic Staples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with chronic lower limb ischemia or aortic, iliac, or femoral aneurysm
• With a scheduled surgery for one of the following indications:
• Femoropopliteal Bypass
• Femorodistal Bypass
• Aortobifemoral Bypass
• Axillofemoral or Axillobifemoral Bypass
• Femorofemoral Bypass
• Femoral Endarterectomy
• 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

You may not qualify if:

• Background of a previous surgical intervention in the groin area.
• 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

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (20)

• 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.

  PMID: 12603990 BACKGROUND

• 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.

  PMID: 32035742 BACKGROUND

• 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.

  PMID: 33236858 BACKGROUND

• 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.

  PMID: 10580621 BACKGROUND

• 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.

  PMID: 33423912 BACKGROUND

• 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.

  PMID: 30300081 BACKGROUND

• 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.

  PMID: 28708024 BACKGROUND

• Engin C, Posacioglu H, Ayik F, Apaydin AZ. Management of vascular infection in the groin. Tex Heart Inst J. 2005;32(4):529-34.

  PMID: 16429897 BACKGROUND

• 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.

  PMID: 637195 BACKGROUND

• 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.

  PMID: 29068153 BACKGROUND

• 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.

  PMID: 16310254 BACKGROUND

• 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.

  PMID: 11925745 BACKGROUND

• 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.

  PMID: 23312940 BACKGROUND

• 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.

  PMID: 26143662 BACKGROUND

• 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.

  PMID: 26926939 BACKGROUND

• 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.

  PMID: 16382265 BACKGROUND

• 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.

  PMID: 24526375 BACKGROUND

• Gonzalez-Sagredo A, Gil Olaria M, D'Oria M, Lopez-Garcia P, Grando B, Gonzalo Villanueva B, Espinar Garcia E, Carnaval T, Llagostera S, Lepidi S, Vila R, Iborra E, Videla S. Randomized clinical trial of intradermal suture and metallic stapling for incisional groin closure after vascular surgery (VASC-INF trial). Br J Surg. 2025 Nov 6;112(11):znaf256. doi: 10.1093/bjs/znaf256.

  PMID: 41289050 DERIVED

• 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(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.

  PMID: 41159585 DERIVED

• 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.

  PMID: 40260835 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elena Iborra, M.D., Ph.D.

  Hospital Universitari de Bellvitge - Angiology and Vascular Surgery Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon at the Vascular Surgery and Angiology Department

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 27, 2022
• Study Start: March 4, 2022
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

ES (1)