Not Yet RecruitingNot Applicable

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

116 participantsStarted 2024-09-01

Plain-language 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

Who can participate

Age range13 Years

SexALL

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Inclusion criteria

✓. Patients age 13yrs and above
✓. Diagnosed with perforated viscus intraoperatively
✓. Undergo Midline Laparotomy
✓. ASA 3 and below

Exclusion criteria

✕. Surgical technique: Laparoscopic washouts
✕. Patients on steroid treatment and immunosuppressant therapy.
✕. More than ASA 3
✕. Inability to give/understand informed consent
✕. Revision-surgery (previous abdominal surgery within the last 30 days)
✕. Planned re-laparotomy within 30 days
✕. Terminal kidney failure requiring dialysis
✕. Concurrent abdominal wall infections

What they're measuring

SSI Incidence

Timeframe: 30 days

Trial details

NCT IDNCT06400394

SponsorUniversiti Sains Malaysia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-01

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