NCT06400394

Impact of Surgical Site Infection in Peritonitis After Peritoneal Lavage With Super-oxidixed Solution: A Randomised Double-Blind, Placebo-controlled Trial

Name: Clinical Trial NCT06400394
Creator: Universiti Sains Malaysia
Keywords: Surgical Site Infection, Hydrocyn Aqua®, device, clinical trial

Universiti Sains Malaysia·ClinicalTrials.gov·device·Device trialNot yet recruiting

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Study focus

Disease/Condition: Surgical Site Infection
Drug/Device/Intervention: Hydrocyn Aqua®
Study type: Interventional
Intervention type: device

Sponsor & location

Primary sponsor: Universiti Sains Malaysia

Timeline & enrollment

Phase: N/A
Start date: Jun 01, 2024
End date: Jun 01, 2025
Enrollment: 116 participants

Primary outcome

SSI Incidence

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

ICD-10 classifications

Infection following a procedure, not elsewhere classifiedBacterial infection of unspecified siteOther bacterial infections of unspecified siteInfection of obstetric surgical woundOther specified local infections of skin and subcutaneous tissue

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06400394
Type: Device Trial

About this record

Access comprehensive clinical trial information for NCT06400394 through Pure Global AI's free database. This phase not specified trial is sponsored by Universiti Sains Malaysia and is currently Not yet recruiting. The study focuses on Surgical Site Infection. Target enrollment is 116 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.