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

Groin Surgical Site Infection Incidence in Vascular Surgery With Intradermal Suture Versus Metallic Stapling Skin Closure: A Pragmatic Open-Label Parallel-Group Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection
• Intervention / Treatment: Procedure: Intradermal Suture; Procedure: Metallic Staples

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Intradermal Suture; Skin closure with an intradermal suture using Monosyn® (Braun®) 4/0 absorbable monofilament.
Active Comparator: 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.	Procedure: Metallic Staples; Skin closure with metallic stapling using Visistat® (Weck®) 35W skin stapler.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number (percentage) of patients with other surgical wound complications up to 28 (±2) days after surgery.	Complications include but are not limited to seroma, hematoma, lymphorrhagia.	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
Types of antibiotic therapy used in patients with SSI		84 (±7) days after surgery
Plasma albumin concentration		Baseline visit to 28 (±2) days after surgery
Body Mass Index		Baseline visit to 28 (±2) days after surgery
Surgical incision length	Length (in centimeters [cm]) of the cutaneous incision performed to gain access to the surgical site. This information will be collected on the day of performing the surgery, once it is over.	On the day of performing the surgical procedure
Total surgery duration	Duration (in minutes) of the surgical procedure. This information will be collected on the day of performing the surgery, once it is over.	On the day of performing the surgical procedure
Type of hemostatic material used during surgery	This information will be collected on the day of performing the surgery, once it is over.	On the day of performing the surgical procedure
Number of days between hospital admission and the surgical intervention	The number of days gone by from hospital admission until the day the surgery is performed. This information will be collected on the day of performing the surgery, once it is over.	From the day of hospital admission to the day of performing the surgical procedure
Number (percentage) of patients who present a femoral approach SSI (superficial and/or deep) up to 84 (±7) days after surgery	According to the NHSN classification	84 (±7) days after surgery

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Investigators: Principal Investigator: Elena Iborra, M.D., Ph.D., Hospital Universitari de Bellvitge - Angiology and Vascular Surgery Department

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Eur J Vasc Endovasc Surg. 2020 Dec;60(6):958. doi: 10.1016/j.ejvs.2020.07.080.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2022
• Primary Completion (Actual): March 14, 2025
• Study Completion (Actual): March 14, 2025

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Surgical Site Infection; Groin; Femoral approach; Intradermal suture; Metallic staples
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Wound Infection; Infections; Surgical Wound Infection
• Other Study ID Numbers: VASC-INF-2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The sponsor will oversee the dataset. Granting access to this information will be evaluated on a case-by-case basis and upon reasonable request by the interested party.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No