NCT03468621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

March 29, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

3.7 years

First QC Date

March 8, 2018

Last Update Submit

April 4, 2022

Conditions

Surgical Wound Infection

Keywords

woundclosuretechniquesurgicalsiteinfectionintrademaltransdermalsuture

Outcome Measures

Primary Outcomes (1)

  • SWI

    Surgical wound infection

    4-6weeks from surgery

Study Arms (2)

Intradermal wound closure

OTHER

Intradermal wound closure of the groin wound

Procedure: Wound closure

Transdermal wound closure

OTHER

Wound closure of the groin wound with metal staples

Procedure: Wound closure

Interventions

Wound closurePROCEDURE

Method of wound closure

Also known as: Intradermal wound closure, Transdermal wound closure
Intradermal wound closureTransdermal wound closure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary procedure to the groin, isolated groin wound

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Keski-Suomen keskussairaala

Jyväskylä, Central Finland, 40620, Finland

Location

Satakunnan keskussairaala

Pori, Satakunta, 28500, Finland

Location

University Hospital of Turku

Turku, Southwest Finland, 20521, Finland

Location

Related Publications (8)

  • Turtiainen J, Saimanen E, Partio T, Karkkainen J, Kiviniemi V, Makinen K, Hakala T. Surgical wound infections after vascular surgery: prospective multicenter observational study. Scand J Surg. 2010;99(3):167-72. doi: 10.1177/145749691009900312.

    PMID: 21044935BACKGROUND

  • Derksen WJ, Verhoeven BA, van de Mortel RH, Moll FL, de Vries JP. Risk factors for surgical-site infection following common femoral artery endarterectomy. Vasc Endovascular Surg. 2009 Feb-Mar;43(1):69-75. doi: 10.1177/1538574408323502. Epub 2008 Sep 30.

    PMID: 18829586BACKGROUND

  • Daryapeyma A, Ostlund O, Wahlgren CM. Healthcare-associated infections after lower extremity revascularization. Eur J Vasc Endovasc Surg. 2014 Jul;48(1):72-7. doi: 10.1016/j.ejvs.2014.02.003. Epub 2014 Mar 6.

    PMID: 24613135BACKGROUND

  • Stewart AH, Eyers PS, Earnshaw JJ. Prevention of infection in peripheral arterial reconstruction: a systematic review and meta-analysis. J Vasc Surg. 2007 Jul;46(1):148-55. doi: 10.1016/j.jvs.2007.02.065.

    PMID: 17606135BACKGROUND

  • Murphy PG, Tadros E, Cross S, Hehir D, Burke PE, Kent P, Sheehan SJ, Colgan MP, Moore DJ, Shanik GD. Skin closure and the incidence of groin wound infection: a prospective study. Ann Vasc Surg. 1995 Sep;9(5):480-2. doi: 10.1007/BF02143863.

    PMID: 8541198BACKGROUND

  • Gurusamy KS, Toon CD, Allen VB, Davidson BR. Continuous versus interrupted skin sutures for non-obstetric surgery. Cochrane Database Syst Rev. 2014 Feb 14;2014(2):CD010365. doi: 10.1002/14651858.CD010365.pub2.

    PMID: 24526375BACKGROUND

  • Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.

    PMID: 41159585DERIVED

  • Nikulainen V, Helmio P, Salminen P, Hurme S, Kukkonen T, Koskinen T, Hakovirta H. Effect of Skin Closure with Metal Staples vs. Intradermal Suture on Groin Infections after Vascular Surgery: A Randomised Controlled Trial. Eur J Vasc Endovasc Surg. 2025 May;69(5):777-782. doi: 10.1016/j.ejvs.2025.02.004. Epub 2025 Feb 7.

    PMID: 39923834DERIVED

MeSH Terms

Conditions

Surgical Wound InfectionInfections

Condition Hierarchy (Ancestors)

Wound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Harri Hakovirta, adj prof.

    harri hakovirta@tyks.fi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Patients are randomised to intradermal and transdermal wound closure techniques. Randomisation is 1:1 and block randomisation is used
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in Vascular Surgery

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 16, 2018

Study Start

March 29, 2018

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

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

Locations

FI(3)