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

Primary Purpose

Surgical Site Infection

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Intradermal Suture

Metallic Staples

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring Femoral approach, Intradermal suture, Metallic staples, Surgical Site Infection, Groin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Universitari de BellvitgeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intradermal Suture Group

Metallic Staples

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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

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

Time of prophylactic antibiotic administration

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

Types of antibiotic therapy used in patients with SSI

Plasma albumin concentration

Body Mass Index

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.

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.

Type of hemostatic material used during surgery

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

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.

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

Full Information

NCT ID

NCT05434182

First Posted

June 16, 2022

Last Updated

June 27, 2022

Sponsor

Hospital Universitari de Bellvitge

1. Study Identification

Unique Protocol Identification Number

NCT05434182

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 4, 2022 (Actual)

Primary Completion Date

May 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Universitari de Bellvitge

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Site Infection

Keywords

Femoral approach, Intradermal suture, Metallic staples, Surgical Site Infection, Groin

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intradermal Suture Group

Arm Type

Experimental

Arm Description

Arm Title

Metallic Staples

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Intradermal Suture

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Metallic Staples

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

According to the National Healthcare Safety Network (NHSN) Classification

Time Frame

28 (±2) days after surgery

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

28 (±2) days after surgery

Title

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

Time Frame

28 (±2) days after surgery

Title

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

Time Frame

28 (±2) days after surgery

Title

Time of prophylactic antibiotic administration

Time Frame

28 (±2) days after surgery

Title

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

Title

Types of antibiotic therapy used in patients with SSI

Time Frame

84 (±7) days after surgery

Title

Plasma albumin concentration

Time Frame

Baseline visit to 28 (±2) days after surgery

Title

Body Mass Index

Time Frame

Baseline visit to 28 (±2) days after surgery

Title

Surgical incision length

Description

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.

Time Frame

On the day of performing the surgical procedure

Title

Total surgery duration

Description

Duration (in minutes) of the surgical procedure. This information will be collected on the day of performing the surgery, once it is over.

Time Frame

On the day of performing the surgical procedure

Title

Type of hemostatic material used during surgery

Description

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

Time Frame

On the day of performing the surgical procedure

Title

Number of days between hospital admission and the surgical intervention

Description

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.

Time Frame

From the day of hospital admission to the day of performing the surgical procedure

Title

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

Description

According to the NHSN classification

Time Frame

84 (±7) days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Albert González-Sagredo, M.D.

Phone

+34932607221

albertgonzalezsagredo@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Elena Iborra, M.D., Ph.D.

Phone

+34932607628

eiborra@bellvitgehospital.cat

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elena Iborra, M.D., Ph.D.

Organizational Affiliation

Hospital Universitari de Bellvitge - Angiology and Vascular Surgery Department

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitari de Bellvitge

City

L'Hospitalet De Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elena Iborra, M.D., Ph.D.

Phone

+34932607628

eiborra@bellvitgehospital.cat

First Name & Middle Initial & Last Name & Degree

Albert González-Sagrero, M.D.

Phone

+34932607221

albertgonzalezsagredo@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The sponsor will oversee the dataset. Granting access to this information will be evaluated on a case-by-case basis and upon reasonable request by the interested party.

Citations:

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12603990

Citation

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

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