Comparing two methods to prevent infections after emergency surgery for peritonitis
Emergency Laparotomy for Peritonitis and Surgical Site Infection: Preventive Subcutaneous NPWT vs Primary Closure - a Randomized Health Services Study
This study is testing whether a special type of wound treatment or regular closure after emergency surgery for peritonitis can better prevent infections in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Gdansk Academic / other |
| Locations | 1 site (Gdańsk, Pomerania) |
| Trial ID | NCT05684198 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of negative pressure wound therapy (NPWT) versus primary closure (PC) in preventing surgical site infections (SSI) in patients undergoing emergency laparotomy for peritonitis. Participants will be randomly assigned to receive either NPWT or PC after their surgery, and both groups will be monitored for one year postoperatively. The study also includes a cost analysis to assess the feasibility of implementing NPWT as a routine preventive measure in similar surgical cases. The goal is to determine which method is more effective in reducing the incidence of SSI and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients who are scheduled for an emergency laparotomy due to peritonitis and can provide informed consent.
Not a fit: Patients who are qualified for open abdomen treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the rate of surgical site infections, leading to shorter hospital stays and improved recovery for patients.
How similar studies have performed: Previous studies have shown promising results for NPWT in reducing surgical site infections, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * qualified for an emergency laparotomy for peritonitis * gave written informed consent Exclusion Criteria: * qualified for open abdomen treatment
Where this trial is running
Gdańsk, Pomerania
- UCC Division of Oncological, Transplant and General Surgery — Gdańsk, Pomerania, Poland (Recruiting)
Study contacts
- Principal investigator: Piotr Spychalski, MD PhD — MUG Division of General Surgery
- Study coordinator: Katarzyna M Polomska
- Email: k.polomska@gumed.edu.pl
- Phone: +48794037928
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.