Lavage With Super-Oxidized Solution for Secondary Peritonitis

Peritonitis Clinical Trial

— SOSPeritonitis  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050253
• Other study ID #: 2020-00603
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: April 2025

Study information

• Verified date: January 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Tobias Haltmeier, MD
• Phone: +41 31 664 03 04
• Email: tobias.haltmeier[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peritonitis

Intervention

Device:
• Super-oxidized solution (SOS)
Peritoneal lavage with super-oxidized solution in patients undergoing emergency abdominal surgery for secondary peritonitis.
• Ringer's solution
Peritoneal lavage with Ringer's solution in patients undergoing emergency abdominal surgery for secondary peritonitis.

Locations

Country	Name	City	State
Switzerland	Inselspital, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

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