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

April 4, 2022 updated by: Veikko Nikulainen, Turku University Hospital

Relation of Skin Closure Method to Groin Wound Infections After Proximal Femoral Artery Exposure, a Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Keski-Suomi
      • Jyväskylä, Keski-Suomi, Finland, 40620
        • Keski-Suomen Keskussairaala
    • Satakunta
      • Pori, Satakunta, Finland, 28500
        • Satakunnan Keskussairaala
    • Varsinais-Suomi
      • Turku, Varsinais-Suomi, Finland, 20521
        • University hospital of Turku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intradermal wound closure
Intradermal wound closure of the groin wound
Procedure: Wound closure
Method of wound closure
Other Names:
  • Intradermal wound closure
  • Transdermal wound closure
Other: Transdermal wound closure
Wound closure of the groin wound with metal staples
Procedure: Wound closure
Method of wound closure
Other Names:
  • Intradermal wound closure
  • Transdermal wound closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SWI
Time Frame: 4-6weeks from surgery
Surgical wound infection
4-6weeks from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

  • Study Director: Harri Hakovirta, adj prof., harri hakovirta@tyks.fi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2018

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

March 8, 2018

First Submitted That Met QC Criteria

March 15, 2018

First Posted (Actual)

March 16, 2018

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • National Wound Infection Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to European and Finnish legislation. The information of individual patients is not possible By other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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