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

Maharishi Markendeswar University (Deemed to be University)

Status and phase: Completed; Phase 2

Conditions: Peritonitis

Treatments: Procedure: Super Oxidized Solution in group I

Study type: Interventional

Funder types: Other

Identifiers

NCT02882932

IEC/MMIMSR/68/14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 290 patients

Sex: All

Ages: 1 day to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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290 participants in 2 patient groups

Super Oxidized Solution

Other group

Description:

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

Treatment:

Procedure: Super Oxidized Solution in group I

normal saline

Other group

Description:

Procedure/Surgery: normal saline In group II - patients underwent normal saline wash and bacterial load was noted.

Treatment:

Procedure: Super Oxidized Solution in group I