CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 225 enrolled
Drug / intervention
Intradermal Suture +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05434182
NCT05434182N/ACompleted

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

Hospital Universitari de Bellvitge·interventional·Posted Jun 27, 2022·Updated Apr 4, 2025

In Brief

A clinical study evaluating Intradermal Suture and Metallic Staples for Surgical Site Infection. Completed, enrolled 225 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedJun 27, 2022
Enrollment StartMar 4, 2022
Primary CompletionMar 14, 2025
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 4.0 years ago

Interventions

Intradermal Sutureprocedure

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

Metallic Staplesprocedure

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