Comparative Evaluation of Intra-operative Peritoneal Lavage With Super Oxidized Solution and Normal Saline in Peritonitis Cases
1 other identifier
interventional
290
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2014
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 16, 2016
CompletedFirst Posted
Study publicly available on registry
August 30, 2016
CompletedAugust 30, 2016
August 1, 2016
4 months
July 16, 2016
August 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
The Results Were Measured In the Form of the, Early Recovery, Early Bowel Sounds
With in 10 -20 days
Study Arms (2)
Super Oxidized Solution
OTHERProcedure/Surgery: Super Oxidized Solution(SOS) in group I - SOS with normal saline solution was used
normal saline
OTHERProcedure/Surgery: normal saline In group II - patients underwent normal saline wash and bacterial load was noted.
Interventions
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.
Eligibility Criteria
You may qualify if:
- gastric, duodenal, ileal perforation, appendicitis
- those patients were willing to participate and the informed consent was taken
You may not qualify if:
- evidence of enteric encephalopathy
- liver diseases
- renal diseases
- heart disease
- known allergy to any substance
- multiple trauma or organ injury
- any gynaecological etiology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 16, 2016
First Posted
August 30, 2016
Study Start
December 1, 2014
Primary Completion
April 1, 2015
Study Completion
November 1, 2015
Last Updated
August 30, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share