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

NCT ID: NCT02882932

Last Updated: 2016-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-11-30

Brief Summary

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.

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.

Conditions

Peritonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Super Oxidized Solution

Procedure/Surgery: Super Oxidized Solution(SOS) in group I - SOS with normal saline solution was used

Group Type: OTHER

Super Oxidized Solution in group I

Intervention Type: PROCEDURE

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.

normal saline

Procedure/Surgery: normal saline

In group II - patients underwent normal saline wash and bacterial load was noted.

Group Type: OTHER

Super Oxidized Solution in group I

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

normal saline solution

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maharishi Markendeswar University (Deemed to be University)

OTHER

Sponsor Role: lead

Responsible Party

DR RIKKI SINGAL

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IEC/MMIMSR/68/14

Identifier Type: -

Identifier Source: org_study_id