Impact of Surgical Site Infection in Peritonitis After Peritoneal Lavage With Super-oxidixed Solution (Plasso 2)

August 1, 2024 updated by: Dinesh Alagoo, Universiti Sains Malaysia

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES

PrimaryOutcome:

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

SecondaryOutcome:

i.To evaluate the effectiveness of peritoneal lavage with super-oxidised solution in reducing inflammatory markers C-reactive protein(CRP) at 24 and 48 hours after open surgery for peritonitis ii.To evaluate the effectiveness of peritoneal lavage with super oxidised solution in reducing duration of post-operative ileus after open surgery for peritonitis.

METHODOLOGY

Study Design This is a randomised double blind placebo controlled parallel group study. This is a superiority study assessing the effectiveness of the intervention. The patients and doctors directly involved in the patient care will be blinded in this study.

Masking Study participants were randomly assigned following computerized block randomization using the website www.randomization.com with a block size of 8 and allocation ratio of 1:1. Allocation sequence and concealment will be performed by the research staff from the Clinical Research Centre who had no clinical involvement in the trial. The allocation sequence will be concealed from the researcher enrolling and assessing the participants in sequentially numbered, opaque, sealed envelopes.

The study participants, healthcare providers who attend to the participants during the trial (surgeon and nurses), outcome evaluators (surgical doctors and nurses) and data collectors will be blinded to the allocation.

2 arms with 56 participants per arm Study group: Peritoneal lavage with super-oxidised solution of at least 1L and wound lavage with super-oxidised solution of 500ml [Super-oxidised solution used in this study is Hydrocyn Aqua® (Vigilenz MD., Penang, Malaysia)] Control group: Peritoneal lavage with normal saline 0.9% 1L and wound lavage with normal saline 0.9% 500ml

Enrollment The estimated total number of participants to be enrolled is about 116 with 20% dropout rate

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Peritoneal lavage with normal saline 0.9% 1L and wound lavage with normal saline 0.9% 500ml
Device: Normal Saline
aqueous solution of electrolytes and other hydrophilic molecules
Experimental: Study group
Peritoneal lavage with super-oxidised solution of at least 1L and wound lavage with super-oxidised solution of 500ml
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SSI Incidence
Time Frame: 30 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRP Level
Time Frame: 24-48 hrs
To evaluate the effectiveness of peritoneal lavage with super-oxidised solution in reducing inflammatory markers C-reactive protein(CRP) at 24 and 48 hours after open surgery for perforated viscus
24-48 hrs
Flatus time
Time Frame: 1-2 days
To evaluate the effectiveness of peritoneal lavage with super oxidised solution in reducing duration of post-operative ileus after open surgery for perforated viscus.
1-2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Collaborators

Hospital Queen Elizabeth, Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

May 1, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSCH ID-24-01241-VGD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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