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Clinical Trials in Sweden / NCT01913132
Recruiting Not applicable

PICO Above Incisions After Vascular Surgery

NCT01913132 · tracked via the Priya Life Science Sweden tracker
Sponsor
Stefan Acosta
Phase
Not applicable
Started
2013-11
Last updated
2024-11-29

Condition(s) studied

WoundInfection

Investigational drug(s) / intervention(s)

Negative pressure wound therapy with PICO (Smith & Nephew)

Negative pressure wound therapy with PICO (Smith & Nephew): Negative wound pressure therapy

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Emergency surgery * Ongoing infection in inguinal area

Primary outcome measure(s)

  • Wound infection rate — Wounds will be checked at 3 month follow-up
    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

Trial sites (1)

FacilityCityRegionStatus
Vascular Centre, Malmö, Skåne University Hospital Malmö Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01913132 on ClinicalTrials.gov ↗ ← All trials in Sweden