Using negative pressure therapy to reduce infections after vascular surgery
PICO Versus Standard Dressing on Groin Incisions After Vascular Surgery - a Prospective Randomized Trial (INVIPS Trial)
NA · Skane University Hospital · NCT01913132
This study is testing if a special type of wound therapy can help prevent infections in patients after they have vascular surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 644 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Skane University Hospital (other) |
| Locations | 1 site (Malmö) |
| Trial ID | NCT01913132 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 and older who are undergoing elective vascular surgery with inguinal incisions.
Not a fit: Patients undergoing emergency surgery or those with ongoing infections in the inguinal area may not benefit from this study.
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 performed: Previous studies have shown promise in using negative pressure wound therapy for reducing infection rates, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Malmö
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Wound, Infection, Negative pressure wound therapy, Vascular Surgery, Inguinal incisions