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

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.

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Key information

Conditions

Peritonitis Digestive System Diseases Infections Intraabdominal Infections Peritoneal Diseases

Age range

1 day–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Super Oxidized Solution in group I

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.

Other names: normal saline solution

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Maharishi Markendeswar University (Deemed to be University)

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Aug 30, 2016
Registry last updated: Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed