Using super-oxidized solution for treating secondary peritonitis during emergency surgery
The Effect of Intraoperative Peritoneal Lavage With Super-Oxidized Solution on Surgical Site Infections and Mortality in Patients With Secondary Peritonitis: A Randomized Controlled Trial
This study is testing if using a special cleaning solution during emergency surgery can help patients with serious abdominal infections have fewer infections and better outcomes compared to a standard solution.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT05050253 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of peritoneal lavage with super-oxidized solution (SOS) compared to the standard Ringer's solution in patients undergoing emergency abdominal surgery for secondary peritonitis. Secondary peritonitis is a serious condition that can lead to high rates of morbidity and mortality due to surgical site infections and sepsis. The study aims to determine if SOS can reduce the incidence of surgical site infections and mortality in this patient population. Eligible patients will be randomized during surgery to receive either SOS or Ringer's solution as part of their treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for emergency abdominal surgery due to secondary peritonitis from conditions like hollow-viscus perforation or abdominal abscess.
Not a fit: Patients with primary or tertiary peritonitis or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce surgical site infections and mortality rates in patients with secondary peritonitis.
How similar studies have performed: While the use of super-oxidized solutions is promising, this specific application in secondary peritonitis is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Secondary peritonitis due to suspected hollow viscus perforation, anastomotic insufficiency, and/or abdominal abscess (including patients with the named abdominal emergencies as a complication after elective surgery) * Scheduled emergency abdominal surgery by laparotomy with peritoneal lavage * Age over 18 years * Written informed consent Exclusion Criteria * Pregnancy (will be ruled out using beta-hCG testing in women of childbearing potential) * Patients with primary or tertiary peritonitis
Where this trial is running
Bern
- Inselspital, Bern University Hospital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Tobias Haltmeier, MD — Inselspital, Bern University Hospital
- Study coordinator: Tobias Haltmeier, MD
- Email: tobias.haltmeier@insel.ch
- Phone: +41 31 664 03 04
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.