Status:

COMPLETED

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

Lead Sponsor:

Hospital Universitari de Bellvitge

Conditions:

Surgical Site Infection

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 4 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 14 2025

Estimated Enrollment :

225 Patients enrolled

Trial Details

Trial ID

NCT05434182

Start Date

March 4 2022

End Date

March 14 2025

Last Update

April 4 2025

Active Locations (1)

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Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain, 08907