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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02882932
Enrollment
290
Registered
2016-08-30
Start date
2014-12-31
Completion date
2015-11-30
Last updated
2016-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritonitis

Keywords

peritonitis, solutions, normal saline, infection, peritoneal lavage

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.

Interventions

PROCEDURESuper Oxidized Solution in group I

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.

Sponsors

Maharishi Markendeswar University (Deemed to be University)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Days to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the investigators measured the infection rate by checking the bacterial load during after surgeryaverage of one yearThe investigators asked about the infection, early recovery

Secondary

MeasureTime frameDescription
The Results Were Measured In the Form of the, Early Recovery, Early Bowel SoundsWith in 10 -20 daysthe condition of the patient measured in the form of early bowel sounds, fever and discharge from the operated area

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026