Clinical trial NCT03468621: Relation of Skin Closure Method to Groin Wound Infections After Proximal Femoral Artery Exposure.
Official title: Relation of Skin Closure Method to Groin Wound Infections After Proximal Femoral Artery Exposure, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Keywords: woundclosure
technique
surgical
site
infection
intrademal
transdermal
suture
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2018-03-16
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomised to intradermal and transdermal wound closure techniques. Randomisation is 1:1 and block randomisation is used
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: SWI
timeFrame: 4-6weeks from surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Keski-Suomen keskussairaala
state: Keski-Suomi
city: Pori
country: Finland
facility: Satakunnan keskussairaala
state: Satakunta
city: Turku
country: Finland
facility: University Hospital of Turku
state: Varsinais-Suomi
Study officials:
affiliation: harri hakovirta@tyks.fi
name: Harri Hakovirta, adj prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.