About this trial
The wound infection rate in the groin after vascular surgery has been denoted to be high since the wound surveillance register started in 2005. The current wound infection rate based on a validation study was 22.9% (24/105 patients with groin incision(s) between 1 March to 30 June in 2012). This randomized controlled trial aims to evaluate if negative pressure wound therapy on closed inguinal incisions (INPWT) after vascular surgical procedures can reduce the risk for surgical site infections and other wound complications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 18 years of age and above
Elective vascular surgery
Inguinal incision (transverse or longitudinal)
Capable of understanding the study information and giving written informed consent
Disqualifiers
Emergency surgery
Ongoing infection in inguinal area
Trial design
Parallel
Treatments tested in this trial
Negative pressure wound therapy with PICO (Smith & Nephew)
DeviceNegative wound pressure therapy
Treatment groups
Trial outcomes
Primary outcomes
Wound infection rate
ASEPSIS (Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the Deep tissues, the isolation of bacteria, and the duration of inpatient stay) score. Min 0 p, max \> 40 p, higher values worse outcome
Secondary outcomes
Overall Costs of treatment
Systematic assessment of overall costs
Sponsors and contacts
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Stefan Acosta
Lead sponsor
Skane University Hospital
Sponsor institution