NCT02882932

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_2

Status
completed

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

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

July 16, 2016

Last Update Submit

August 24, 2016

Conditions

Keywords

peritonitissolutionsnormal salineinfectionperitoneal lavage

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

OTHER

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

Procedure: Super Oxidized Solution in group I

normal saline

OTHER

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

Procedure: Super Oxidized Solution in group I

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.

Also known as: normal saline solution
Super Oxidized Solutionnormal saline

Eligibility Criteria

Age1 Day - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

PeritonitisInfections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsPeritoneal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

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