Lavage With Super-Oxidized Solution for Secondary Peritonitis (SOSPeritonitis)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peritonitis
• Intervention / Treatment: Device: Super-oxidized solution (SOS); Device: Ringer's solution

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tobias Haltmeier, MD; Phone Number: +41 31 664 03 04; Email: tobias.haltmeier@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital, Bern University Hospital
    • Contact: Tobias Haltmeier, MD; Phone Number: +41 31 664 03 04; Email: tobias.haltmeier@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOS group; Peritoneal lavage with super-oxidized solution (SOS)	Device: Super-oxidized solution (SOS); Peritoneal lavage with super-oxidized solution in patients undergoing emergency abdominal surgery for secondary peritonitis.
Active Comparator: Control group; Peritoneal lavage with Ringer's solution	Device: Ringer's solution; Peritoneal lavage with Ringer's solution in patients undergoing emergency abdominal surgery for secondary peritonitis.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Tobias Haltmeier, MD, Inselspital, Bern University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Mortality; Surgical site infection; Secondary peritonitis; Emergency abdominal surgery; Super-oxidized solution
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Intraabdominal Infections; Peritonitis; Pharmaceutical Solutions
• Other Study ID Numbers: 2020-00603

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No