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

Peritonitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882932
• Other study ID #: IEC/MMIMSR/68/14
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2016
• Last updated: August 24, 2016
• Start date: December 2014
• Est. completion date: November 2015

Study information

• Verified date: August 2016
• Source: Maharishi Markendeswar University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: November 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peritonitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maharishi Markendeswar University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the investigators measured the infection rate by checking the bacterial load during after surgery	The investigators asked about the infection, early recovery	average of one year	Yes
Secondary	The Results Were Measured In the Form of the, Early Recovery, Early Bowel Sounds	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	Yes