NCT05050253

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 21, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

September 9, 2021

Last Update Submit

January 8, 2024

Conditions

Peritonitis

Keywords

Secondary peritonitisEmergency abdominal surgerySuper-oxidized solutionSurgical site infectionMortality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

  • In-hospital mortality

    Hospital stay, expected to be up to two weeks

  • 30-day mortality

    30 days

  • Surgical site infection

    30 days

  • Time to primary outcome

    30 days

  • Sepsis

    7 days

  • +12 more secondary outcomes

Study Arms (2)

SOS group

EXPERIMENTAL

Peritoneal lavage with super-oxidized solution (SOS)

Device: Super-oxidized solution (SOS)

Control group

ACTIVE COMPARATOR

Peritoneal lavage with Ringer's solution

Device: Ringer's solution

Interventions

Super-oxidized solution (SOS)DEVICE

Peritoneal lavage with super-oxidized solution in patients undergoing emergency abdominal surgery for secondary peritonitis.

SOS group
Ringer's solutionDEVICE

Peritoneal lavage with Ringer's solution in patients undergoing emergency abdominal surgery for secondary peritonitis.

Control group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy (will be ruled out using beta-hCG testing in women of childbearing potential)
  • Patients with primary or tertiary peritonitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

PeritonitisSurgical Wound Infection

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System DiseasesWound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tobias Haltmeier, MD

    Inselspital, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Haltmeier, MD

CONTACT

+41 31 664 03 04tobias.haltmeier@insel.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 20, 2021

Study Start

March 21, 2023

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

January 11, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)