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Completed

NCT Number: NCT05434182

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intradermal Suture

Procedure

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

Metallic Staples

Procedure

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

Primary outcomes

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

    Time frame: 28 (±2) days after surgery

    According to the National Healthcare Safety Network (NHSN) Classification

Secondary outcomes

  1. Number (percentage) of patients with other surgical wound complications up to 28 (±2) days after surgery.

    Time frame: 28 (±2) days after surgery

    Complications include but are not limited to seroma, hematoma, lymphorrhagia.

  2. Number (percentage) of patients who develop sepsis up to 28 (±2) days after surgery

    Time frame: 28 (±2) days after surgery

  3. Number (percentage) of patients with SSI who develop sepsis up to 28 (±2) days after surgery.

    Time frame: 28 (±2) days after surgery

  4. Time of prophylactic antibiotic administration

    Time frame: 28 (±2) days after surgery

  5. Types of microorganisms isolated from skin microbiological culture, subcutaneous tissue sample culture, and SSI secretion culture up to 28 (±2) days after surgery.

    Time frame: 28 (±2) days after surgery

  6. Types of antibiotic therapy used in patients with SSI

    Time frame: 84 (±7) days after surgery

  7. Plasma albumin concentration

    Time frame: Baseline visit to 28 (±2) days after surgery

  8. Body Mass Index

    Time frame: Baseline visit to 28 (±2) days after surgery

  9. Surgical incision length

    Time frame: 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.

  10. Total surgery duration

    Time frame: 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.

  11. Type of hemostatic material used during surgery

    Time frame: On the day of performing the surgical procedure

    This information will be collected on the day of performing the surgery, once it is over.

  12. Number of days between hospital admission and the surgical intervention

    Time frame: 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.

  13. Number (percentage) of patients who present a femoral approach SSI (superficial and/or deep) up to 84 (±7) days after surgery

    Time frame: 84 (±7) days after surgery

    According to the NHSN classification

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2022
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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