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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05050253
Other study ID # 2020-00603
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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