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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Procedure: Intradermal Suture
* Procedure: Metallic Staples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intradermal Suture Group<br>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. | Procedure: Intradermal Suture<br>* Skin closure with an intradermal suture using Monosyn® (Braun®) 4/0 absorbable monofilament.<br>|
| Active Comparator: Metallic Staples<br>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. | Procedure: Metallic Staples<br>* Skin closure with metallic stapling using Visistat® (Weck®) 35W skin stapler.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number (percentage) of patients who present a femoral approach SSI* -(superficial and/or deep) up to 28 (±2) after surgery. | According to the National Healthcare Safety Network (NHSN) Classification | 28 (±2) days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number (percentage) of patients with other surgical wound complications up to 28 (±2) days after surgery. | Complications include but are not limited to seroma, hematoma, lymphorrhagia. | 28 (±2) days after surgery | 
| Number (percentage) of patients who develop sepsis up to 28 (±2) days after surgery |  | 28 (±2) days after surgery | 
| Number (percentage) of patients with SSI who develop sepsis up to 28 (±2) days after surgery. |  | 28 (±2) days after surgery | 
| Time of prophylactic antibiotic administration |  | 28 (±2) days after surgery | 
| Types of microorganisms isolated from skin microbiological culture, subcutaneous tissue sample culture, and SSI secretion culture up to 28 (±2) days after surgery. |  | 28 (±2) days after surgery | 
| Types of antibiotic therapy used in patients with SSI |  | 84 (±7) days after surgery | 
| Plasma albumin concentration |  | Baseline visit to 28 (±2) days after surgery | 
| Body Mass Index |  | Baseline visit to 28 (±2) days after surgery | 
| Surgical incision length | 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. | On the day of performing the surgical procedure | 
| Total surgery duration | Duration (in minutes) of the surgical procedure. This information will be collected on the day of performing the surgery, once it is over. | On the day of performing the surgical procedure | 
| Type of hemostatic material used during surgery | This information will be collected on the day of performing the surgery, once it is over. | On the day of performing the surgical procedure | 
| Number of days between hospital admission and the surgical intervention | 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. | From the day of hospital admission to the day of performing the surgical procedure | 
| Number (percentage) of patients who present a femoral approach SSI (superficial and/or deep) up to 84 (±7) days after surgery | According to the NHSN classification | 84 (±7) days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Groin, Femoral approach, Intradermal suture, Metallic staples, Surgical Site Infection