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

Primary Purpose

Peritonitis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Super Oxidized Solution in group I

About this trial

This is an interventional treatment trial for Peritonitis focused on measuring peritonitis, solutions, normal saline, infection, peritoneal lavage

Eligibility Criteria

1 Day - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Super Oxidized Solution

normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

the investigators measured the infection rate by checking the bacterial load during after surgery

The investigators asked about the infection, early recovery

Secondary Outcome Measures

The Results Were Measured In the Form of the, Early Recovery, Early Bowel Sounds

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

Full Information

NCT ID

NCT02882932

First Posted

July 16, 2016

Last Updated

August 24, 2016

Sponsor

Maharishi Markendeswar University (Deemed to be University)

1. Study Identification

Unique Protocol Identification Number

NCT02882932

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Maharishi Markendeswar University (Deemed to be University)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peritonitis

Keywords

peritonitis, solutions, normal saline, infection, peritoneal lavage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

290 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Super Oxidized Solution

Arm Type

Other

Arm Description

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

Arm Title

normal saline

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Super Oxidized Solution in group I

Other Intervention Name(s)

normal saline solution

Intervention Description

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.

Primary Outcome Measure Information:

Title

the investigators measured the infection rate by checking the bacterial load during after surgery

Description

The investigators asked about the infection, early recovery

Time Frame

average of one year

Secondary Outcome Measure Information:

Title

The Results Were Measured In the Form of the, Early Recovery, Early Bowel Sounds

Description

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

Time Frame

With in 10 -20 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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