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

NCT06400394 | Not Yet Recruiting

• 1 other identifier: RSCH ID-24-01241-VGD
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

"Peritonitis" "Peritoneal lavage" "surgical site infection" "super-oxidised solution"

Outcome Measures

Primary Outcomes (1)

• SSI Incidence

  To evaluate the effectiveness of peritoneal lavage with superoxidised solution in reducing incidence of surgical site infection after open surgery for perforated viscus.

  30 days

Secondary Outcomes (2)

• CRP Level

  24-48 hrs

• Flatus time

  1-2 days

Study Arms (2)

Control group

PLACEBO COMPARATOR

Peritoneal lavage with normal saline 0.9% 1L and wound lavage with normal saline 0.9% 500ml

Device: Normal Saline

Study group

EXPERIMENTAL

Peritoneal lavage with super-oxidised solution of at least 1L and wound lavage with super-oxidised solution of 500ml

Device: Hydrocyn Aqua®

Interventions

Hydrocyn Aqua® DEVICE

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

Study group

Normal Saline DEVICE

aqueous solution of electrolytes and other hydrophilic molecules

Control group

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Hospital Queen Elizabeth, Malaysia: collaborator

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: computerized block randomization using the website www.randomization.com with a block size of 8 and allocation ratio of 1:1
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: a randomised double blind placebo controlled parallel group study

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 6, 2024
• Study Start: September 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: May 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08