Using negative pressure therapy to reduce infections after vascular surgery
Official title: PICO Versus Standard Dressing on Groin Incisions After Vascular Surgery - a Prospective Randomized Trial (INVIPS Trial)
Run by Skane University Hospital · NCT01913132 · Data updated 2026-11-12
This study is testing if a special type of wound therapy can help prevent infections in patients after they have vascular surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 644 (estimated) |
| Sponsor | Skane University Hospital Academic / other |
| Locations | 1 site (Malmö) |
| Status | Recruiting |
| Started | November 2013 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | November 29, 2024 |
| Trial ID | NCT01913132 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 18 and older who are undergoing elective vascular surgery with inguinal incisions.
✕Probably not a fit
Patients undergoing emergency surgery or those with ongoing infections in the inguinal area may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of negative pressure wound therapy (PICO) on closed inguinal incisions following vascular surgical procedures. The study aims to determine if this intervention can significantly reduce the rate of surgical site infections and other wound complications. It includes two arms: one for endovascular aortic repair (EVAR) and another for open vascular procedures, with specific targets for infection rate reduction. The trial is designed to ensure robust statistical power and minimize bias through objective wound assessment.
Why it matters
Potential benefit: If successful, this approach could significantly lower the incidence of infections and complications for patients undergoing vascular surgery.
How similar studies have gone: Previous studies have shown promise in using negative pressure wound therapy for reducing infection rates, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Vascular Centre, Malmö, Skåne University Hospital
Malmö, Sweden Recruiting
Study contacts
- Principal investigator: Stefan Acosta, MD PhD — Vascular Centre, Malmö, Skåne University Hospital
- Study coordinator: Stefan Acosta, MD PhD
- Email: stefan.acosta@med.lu.se
- Phone: +4640331000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.