CompletedNot Applicable

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

Spain225 participantsStarted 2022-03-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number (percentage) of patients who present a femoral approach SSI* -(superficial and/or deep) up to 28 (±2) after surgery.

Timeframe: 28 (±2) days after surgery

Trial details

NCT IDNCT05434182

SponsorHospital Universitari de Bellvitge

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-14

View on ClinicalTrials.gov More Surgical Site Infection trials