Relation of Skin Closure Method to Groin Wound Infections After Proximal Femoral Artery Exposure.
NCT ID: NCT03468621
Last Updated: 2022-04-05
Study Results
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Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2018-03-29
2022-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intradermal wound closure
Intradermal wound closure of the groin wound
Wound closure
Method of wound closure
Transdermal wound closure
Wound closure of the groin wound with metal staples
Wound closure
Method of wound closure
Interventions
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Wound closure
Method of wound closure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Turku University Hospital
OTHER_GOV
Responsible Party
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Veikko Nikulainen
Resident in Vascular Surgery
Principal Investigators
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Locations
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Keski-Suomen keskussairaala
Jyväskylä, Central Finland, Finland
Satakunnan keskussairaala
Pori, Satakunta, Finland
University Hospital of Turku
Turku, Southwest Finland, Finland
Countries
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References
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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.
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.
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.
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.
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.
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.
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:CD015022. doi: 10.1002/14651858.CD015022.pub2.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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National Wound Infection Study
Identifier Type: -
Identifier Source: org_study_id
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