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

NCT05434182 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2025-04-04

No results posted yet for this study

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

Interventions

PROCEDURE

Intradermal Suture

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

PROCEDURE

Metallic Staples

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

Sponsors & Collaborators

  • Hospital Universitari de Bellvitge

    lead OTHER

Principal Investigators

  • Elena Iborra, M.D., Ph.D. · Hospital Universitari de Bellvitge - Angiology and Vascular Surgery Department

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-04
Primary Completion
2025-03-14
Completion
2025-03-14

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05434182 on ClinicalTrials.gov