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

Phase 2
Completed
Conditions
Peritonitis
Interventions
Procedure: Super Oxidized Solution in group I
Registration Number
NCT02882932
Lead Sponsor
Maharishi Markendeswar University (Deemed to be University)
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
290
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Super Oxidized SolutionSuper Oxidized Solution in group IProcedure/Surgery: Super Oxidized Solution(SOS) in group I - SOS with normal saline solution was used
normal salineSuper Oxidized Solution in group IProcedure/Surgery: normal saline In group II - patients underwent normal saline wash and bacterial load was noted.
Primary Outcome Measures
NameTimeMethod
the investigators measured the infection rate by checking the bacterial load during after surgeryaverage of one year

The investigators asked about the infection, early recovery

Secondary Outcome Measures
NameTimeMethod
The Results Were Measured In the Form of the, Early Recovery, Early Bowel SoundsWith in 10 -20 days

the condition of the patient measured in the form of early bowel sounds, fever and discharge from the operated area

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