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

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.