Clinical trial NCT05434182: Intradermal Suture Versus Stapling for Groin Skin Closure in Vascular Surgery (VASC-INF Trial)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Keywords: Femoral approach
Intradermal suture
Metallic staples
Surgical Site Infection
Groin
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Number (percentage) of patients with other surgical wound complications up to 28 (±2) days after surgery.
timeFrame: 28 (±2) days after surgery
measure: Number (percentage) of patients who develop sepsis up to 28 (±2) days after surgery
timeFrame: 28 (±2) days after surgery
measure: Number (percentage) of patients with SSI who develop sepsis up to 28 (±2) days after surgery.
timeFrame: 28 (±2) days after surgery
measure: Time of prophylactic antibiotic administration
timeFrame: 28 (±2) days after surgery
measure: Types of microorganisms isolated from skin microbiological culture, subcutaneous tissue sample culture, and SSI secretion culture up to 28 (±2) days after surgery.
timeFrame: 28 (±2) days after surgery
measure: Types of antibiotic therapy used in patients with SSI
timeFrame: 84 (±7) days after surgery
measure: Plasma albumin concentration
timeFrame: Baseline visit to 28 (±2) days after surgery
measure: Body Mass Index
timeFrame: Baseline visit to 28 (±2) days after surgery
measure: Surgical incision length
timeFrame: On the day of performing the surgical procedure
measure: Total surgery duration
timeFrame: On the day of performing the surgical procedure
measure: Type of hemostatic material used during surgery
timeFrame: On the day of performing the surgical procedure
measure: Number of days between hospital admission and the surgical intervention
timeFrame: From the day of hospital admission to the day of performing the surgical procedure
measure: Number (percentage) of patients who present a femoral approach SSI (superficial and/or deep) up to 84 (±7) days after surgery
timeFrame: 84 (±7) days after surgery
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Hospital Universitari de Bellvitge - Angiology and Vascular Surgery Department
name: Elena Iborra, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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