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

Not Applicable

Completed

• Conditions: Surgical Site Infection
• Interventions: Procedure: Intradermal Suture; Procedure: Metallic Staples

• Registration Number: NCT05434182
• Lead Sponsor: Hospital Universitari de Bellvitge

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-04
• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-27
• Status Verified: 2025-03
• Primary Completion: 2025-03-14
• Study Completion: 2025-03-14
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intradermal Suture Group	Intradermal Suture	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.
Metallic Staples	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.

Primary Outcome Measures

Name	Time	Method
Number (percentage) of patients who present a femoral approach SSI* -(superficial and/or deep) up to 28 (±2) after surgery.	28 (±2) days after surgery	According to the National Healthcare Safety Network (NHSN) Classification

Secondary Outcome Measures

Name	Time	Method
Number (percentage) of patients who develop sepsis 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
Number (percentage) of patients with other surgical wound complications up to 28 (±2) days after surgery.	28 (±2) days after surgery	Complications include but are not limited to seroma, hematoma, lymphorrhagia.
Number (percentage) of patients with SSI who develop sepsis up to 28 (±2) days after surgery.	28 (±2) days after surgery
Plasma albumin concentration	Baseline visit to 28 (±2) days after surgery
Number (percentage) of patients who present a femoral approach SSI (superficial and/or deep) up to 84 (±7) days after surgery	84 (±7) days after surgery	According to the NHSN classification
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
Total surgery duration	On the day of performing the surgical procedure	Duration (in minutes) of the surgical procedure. This information will be collected on the day of performing the surgery, once it is over.
Type of hemostatic material used during surgery	On the day of performing the surgical procedure	This information will be collected on the day of performing the surgery, once it is over.
Body Mass Index	Baseline visit to 28 (±2) days after surgery
Surgical incision length	On the day of performing the surgical procedure	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.
Number of days between hospital admission and the surgical intervention	From the day of hospital admission to the day of performing the surgical procedure	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.

Trial Locations

Locations (1)

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet De Llobregat, Barcelona, Spain