Relation of Skin Closure Method to Groin Wound Infections After Proximal Femoral Artery Exposure.

Not Applicable

Completed

• Conditions: Surgical Wound Infection
• Interventions: Procedure: Wound closure

• Registration Number: NCT03468621
• Lead Sponsor: Turku University Hospital

Brief Summary

This study aims to asses whether the rate of surgical wound infections in vascular surgery procedures involving exposure of the proximal femoral artery can be reduced using a different skin closure technique.

Detailed Description

Summary of the research plan

Background - According to published articles the frequency of groin wound infections after peripheral revascularization varies substantially depending on the source from 5% up to 27%.

Aims of the study - The aim of this randomized clinical trial is to evaluate whether the number of groin wound infections can be reduced with an intradermal skin suture compared to the commonly used metal staples skin closure method.

Methods and study design - This is a randomized clinical trial of patients undergoing a vascular procedure which includes an incision in the groin. The patients will be randomized (1:1) to two different wound closure techniques: subcuticular suture or metal staples. After the procedure the patients will be controlled for four to six weeks and the infection rate in each group is recorded. A clinical diagnosis of infection according to Centre for Disease Control (CDC) guidelines will be recorded, no microbiological samples will be routinely collected.

Statistical analysis - A power analysis has been conducted based on Finnish RCT studies and a retrospective study from our own hospital (submitted to Annals of Vascular Surgery 1/2018) which included all isolated groin wounds from Turku University Hospital Vascular Surgery clinic 2015-2016. According to this analysis between 130-150 patients are needed for each group.

Time and schedule- This is a multicenter trial. Ethical committee approval was acquired in 2015. The randomization will start in the spring of 2018 in the University Hospital of Turku. Later in the year in the other hospitals that are participating in the study once the regional authorities have given their consent.

Ethical aspects - Ethical committee approval was obtained in 2015. The wound closure techniques are all in everyday use already, nothing new and experimental will be used.

Budget - This study is a critical part of quality control and improvement in vascular surgery. The funding will be applied from the Finnish Academy and EVO funding from the ERVA.

Study Timeline

• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-16
• Study Start: 2018-03-29
• Primary Completion: 2021-12-01
• Study Completion: 2022-01-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Primary procedure to the groin, isolated groin wound

Exclusion Criteria

• Emergency procedure, secondary procedure, wound is a part of a larger wound in the same limb

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intradermal wound closure	Wound closure	Intradermal wound closure of the groin wound
Transdermal wound closure	Wound closure	Wound closure of the groin wound with metal staples

Primary Outcome Measures

Name	Time	Method
SWI	4-6weeks from surgery	Surgical wound infection

Trial Locations

Locations (3)

University Hospital of Turku; 🇫🇮 Turku, Varsinais-Suomi, Finland

Satakunnan keskussairaala; 🇫🇮 Pori, Satakunta, Finland

Keski-Suomen keskussairaala; 🇫🇮 Jyväskylä, Keski-Suomi, Finland