NCT05434182

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-03-04
• Primary completion: 2025-03-14
• Completion: 2025-03-14
• First posted: 2022-06-27
• Last updated: 2025-04-04

Locations

1 site across 1 country: Spain