Comparative Evaluation of Intra-operative Peritoneal Lavage With Super Oxidized Solution and Normal Saline in Peritonitis Cases

August 24, 2016 updated by: DR RIKKI SINGAL, Maharishi Markendeswar University (Deemed to be University)
Super Oxidized Solution (SOS) was used in peritonitis and results were compared by using normal saline solution in two groups. Abdominal fluid was taken to check for bacterial load after giving lavage with SOS solution and in other group normal saline. SOS is a high level disinfectant, non-flammable and no special training is required to handle it.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim - To investigate the efficacy of super-oxidized solution (SOS) over normal saline in peritonitis. The investigators objectives are to present the potential clinical impact of intraperitoneal lavage with solutions for early recovery of the patient by reducing the infection rate.

Methods - A double-blind random clinical trial was performed in 240 patients diagnosed as peritonitis at MMIMSR, Mullana, Ambala, India, from December 2014 - November 2015. Subjects were divided into 2 groups, i.e. 120 patients in the study group and 120 cases in the control group. Both the groups underwent peritoneal lavage ; the study group received SOS where as control group underwent normal saline lavage. The effectiveness of both the solutions were compared.

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Phase 2

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

1 day to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • gastric, duodenal, ileal perforation, appendicitis
  • those patients were willing to participate and the informed consent was taken

Exclusion criteria:

  • evidence of enteric encephalopathy
  • liver diseases
  • renal diseases
  • heart disease
  • known allergy to any substance
  • multiple trauma or organ injury
  • any gynaecological etiology

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Super Oxidized Solution
Procedure/Surgery: Super Oxidized Solution(SOS) in group I - SOS with normal saline solution was used
Procedure: Super Oxidized Solution in group I
Two groups were made as group I and group II. Peritoneal Lavage was given with SOS and normal saline in group I. in group II only normal saline wash was given.
Other Names:
  • normal saline solution
Other: normal saline

Procedure/Surgery: normal saline

In group II - patients underwent normal saline wash and bacterial load was noted.
Procedure: Super Oxidized Solution in group I
Two groups were made as group I and group II. Peritoneal Lavage was given with SOS and normal saline in group I. in group II only normal saline wash was given.
Other Names:
  • normal saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the investigators measured the infection rate by checking the bacterial load during after surgery
Time Frame: average of one year
The investigators asked about the infection, early recovery
average of one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Results Were Measured In the Form of the, Early Recovery, Early Bowel Sounds
Time Frame: With in 10 -20 days
the condition of the patient measured in the form of early bowel sounds, fever and discharge from the operated area
With in 10 -20 days

Collaborators and Investigators

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

Sponsor

Maharishi Markendeswar University (Deemed to be University)

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

December 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

July 16, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEC/MMIMSR/68/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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