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Impact of Surgical Site Infection in Peritonitis After Peritoneal Lavage With Super-oxidixed Solution

NCT06400394 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2024-08-06

No results posted yet for this study

Summary

This is randomised double blinded placebo-controlled parallel-group study. Patients in Hospital Queen Elizabeth, Sabah and Hospital Universiti Sains Malaysia, Kelantan who undergo laparotomy for peritonitis will be equally randomised into two groups : intervention group receiving super-oxidised solution and the control group receiving normal saline during peritoneal and wound lavage.

This is a superiority study assessing the effectiveness of the intervention. The patient and doctors directly involved in the partient care will be blinded in this study

Conditions

  • Surgical Site Infection

Interventions

DEVICE

Hydrocyn Aqua®

The study solution comes in a liquid form containing hypochlorous acid (HOCl) in a concentration of 0.003%. It is used as a topical agent for wound and peritoneal lavage before wound closure

DEVICE

Normal Saline

aqueous solution of electrolytes and other hydrophilic molecules

Sponsors & Collaborators

  • Hospital Queen Elizabeth, Malaysia

    collaborator OTHER_GOV

  • Universiti Sains Malaysia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-10-01
Completion
2026-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06400394 on ClinicalTrials.gov