Lavage With Super-Oxidized Solution for Secondary Peritonitis

Not Applicable

Recruiting

• Conditions: Peritonitis
• Interventions: Device: Super-oxidized solution (SOS); Device: Ringer's solution

• Registration Number: NCT05050253
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

Secondary peritonitis is a frequent abdominal emergency that is still associated with a high morbidity and mortality rate due to surgical site infections (SSI) and sepsis. Early surgical source control is crucial to avoid sepsis and worse outcomes. The current randomized controlled trial aims to investigate the effect of peritoneal lavage with super-oxidized solution (SOS) on SSI and mortality in patients undergoing emergency abdominal surgery for secondary peritonitis. The investigators hypothesize that peritoneal lavage with SOS reduces the incidence of SSI and mortality in this patient population.

Detailed Description

Secondary peritonitis is a frequent abdominal emergency that is associated with significant mortality and morbidity, especially surgical site infections (SSI). If not treated promptly and efficiently, secondary peritonitis may progress from a contained abdominal infection to systemic disease, i.e., sepsis and eventually septic shock. Early surgical source control is crucial to avoid sepsis and worse outcomes. Super-oxidized solution (SOS) has been shown to have a strong antimicrobial activity while being safe for medical use in humans.

This randomized controlled trial (RCT) will investigate the effect of peritoneal lavage with SOS vs. the current standard solution (Ringer) on SSI and mortality in patients undergoing emergency abdominal surgery (EAS) for secondary peritonitis. The hypothesis of this study is that peritoneal lavage with SOS during EAS will reduce the incidence of SSI and mortality.

Patients scheduled for open EAS with secondary peritonitis due to suspected hollow-viscus perforation, anastomotic insufficiency, or abdominal abscess, including patients with the named abdominal emergencies as a complication after elective surgery, will be assessed for eligibility. All patients included will be treated according to the current standard of care for secondary peritonitis. This includes the insertion of intravenous lines, start of antibiotic therapy, infusion of crystalloid solutions, monitoring of vital signs, and EAS.

Randomization will take place during EAS after the surgical procedure including regular peritoneal lavage have been performed. If a hollow-viscus perforation, anastomotic insufficiency, or an abdominal abscess is encountered intraoperatively, patients will be randomized and undergo additional peritoneal lavage with either SOS (SOS group) or Ringer's solution (control group).

In the SOS group, the abdominal cavity will be irrigated with 2 liters of SOS (Micodacyn60®), followed by aspiration of the product and abdominal closure. In the control group, the abdominal cavity will be irrigated with two liters of Ringer's solution, followed by aspiration of the solution and abdominal closure. The only difference in treatment between the two groups will be the additional peritoneal lavage with SOS or Ringer's solution at the end of the procedure. After surgery, there will be no difference in the management of the SOS and control group.

The primary outcome of this RCT will be the incidence of SSI and mortality as a composite outcome at 30 days postoperatively.

Secondary outcomes will be in-hospital and 30-day mortality, surgical site infections within 30 days, the time to occurrence of the primary outcome, sepsis as defined by the Sepsis-3 guidelines at 24 h, 48 h, and 7 days postoperatively, septic shock as defined by the Sepsis-3 guidelines at 24 h, 48 h, and 7 days postoperatively, organ dysfunction over time (14 days, as measured by SOFA and/or qSOFA scores), biomarkers of inflammation over time (14 days, including C-reactive protein, white blood cell count, and body temperature), postoperative fascial dehiscence at 30 days postoperatively, intestinal fistula at 30 days postoperatively, re-intervention for postoperative complications within 30 days postoperatively, days to first postoperative bowel movement, and total hospital and Intensive Care Unit length of stay.

Data will be collected during the hospital stay and a the follow-up visit 30 days postoperatively. Data assessors will be blinded for the study procedure.

Study Timeline

• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-20
• Study Start: 2023-03-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-11
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOS group	Super-oxidized solution (SOS)	Peritoneal lavage with super-oxidized solution (SOS)
Control group	Ringer's solution	Peritoneal lavage with Ringer's solution

Primary Outcome Measures

Name	Time	Method
Composite endpoint of surgical site infection and mortality	30 days	The primary composite endpoint will be the proportion of patients who have a surgical site infection or die within 30 days postoperatively.

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality	Hospital stay, expected to be up to two weeks
White blood count	14 days	White blood count over time, i.e., 14 days postoperatively
Reintervention for postoperative complications	30 days
Time to primary outcome	30 days	Time to occurrence of surgical site infection or death
30-day mortality	30 days
Sepsis	7 days	Sepsis as defined by the Sepsis-3 guidelines at 24 h, 48 h, and 7 days postoperatively
Intensive care unit length of stay	Intensive care unit stay, expected to be up to one week
Surgical site infection	30 days
Postoperative intestinal fistula	30 days
Total hospital length of stay	Hospital stay, expected to be up to two weeks
Septic shock	7 days	Septic shock as defined by the Sepsis-3 guidelines at 24 h, 48 h, and 7 days postoperatively
Organ dysfunction based on SOFA score	14 days	Organ dysfunction over time, i.e., 14 days postoperatively, as measured by the SOFA score
C-reactive protein	14 days	C-reactive protein over time, i.e., 14 days postoperatively
Body temperature	14 days	Body temperature over time, i.e., 14 days postoperatively
Postoperative fascial dehiscence	30 days
Time to first postoperative bowel movement	30 days
Organ dysfunction based on qSOFA score	14 days	Organ dysfunction over time, i.e., 14 days postoperatively, as measured by the quick SOFA (qSOFA) score

Trial Locations

Locations (1)

Inselspital, Bern University Hospital; 🇨🇭 Bern, Switzerland