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

Catalan Institute of Health

Status: Completed

Conditions: Surgical Site Infection

Treatments: Procedure: Intradermal Suture; Procedure: Metallic Staples

Study type: Interventional

Funder types: Other

Identifiers

NCT05434182

VASC-INF-2021-01

Details and patient eligibility

About

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.

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 2 patient groups

Intradermal Suture Group

Experimental group

Description:

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.

Treatment:

Procedure: Intradermal Suture

Metallic Staples

Active Comparator group

Description:

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.

Treatment:

Procedure: Metallic Staples