PeritonitisPhase 2NCT02882932
Comparative Evaluation of Intra-operative Peritoneal Lavage With Super Oxidized Solution and Normal Saline in Peritonitis Cases
A Phase 2 study testing Super Oxidized Solution in group I in people with Peritonitis, run by Maharishi Markendeswar University (Deemed to be University).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 90 years
- Conditions the study is for
- Peritonitis
- What is being tested?
- Super Oxidized Solution in group I
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Nov 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- gastric, duodenal, ileal perforation, appendicitis
- those patients were willing to participate and the informed consent was taken
Who cannot join
- evidence of enteric encephalopathy
- liver diseases
- renal diseases
- heart disease
- known allergy to any substance
- multiple trauma or organ injury
- any gynaecological etiology
About this study
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.
Read the 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.
- Conditions
- Peritonitis
- Being tested
- Super Oxidized Solution in group I
- Keywords
- peritonitis, solutions, normal saline, infection, peritoneal lavage
- Medical subject headings
- Peritonitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super Oxidized Solution in group IProcedure or surgery
Also called normal saline solution
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.
| Study group | Role | What they receive |
|---|---|---|
| Super Oxidized Solution | Other | Procedure/Surgery: Super Oxidized Solution(SOS) in group I - SOS with normal saline solution was used Receives: 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. Receives: Procedure: Super Oxidized Solution in group I |
What is being measured
The primary outcome is the main question the study is designed to answer.
the investigators measured the infection rate by checking the bacterial load during after surgery
The investigators asked about the infection, early recovery
Measured: average of one year
Secondary outcomes (1)
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
Measured: With in 10 -20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR RIKKI SINGAL, Maharishi Markendeswar University (Deemed to be University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882932
- Sponsor's protocol ID
- IEC/MMIMSR/68/14
- Status last verified
- Aug 2016
- First submitted
- 16 Jul 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Intra-operative Peritoneal Lavage With Super Oxidized Solution and Normal Saline in Peritonitis Cases
- ClinicalTrials.gov ID
- NCT02882932
- Acronym / sponsor ID
- IEC/MMIMSR/68/14
- Conditions
- Peritonitis
- Keywords
- peritonitis, solutions, normal saline, infection, peritoneal lavage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Super Oxidized Solution | Other | Procedure: Super Oxidized Solution in group IProcedure/Surgery: Super Oxidized Solution(SOS) in group I - SOS with normal saline solution was used |
| normal saline | Other | Procedure: Super Oxidized Solution in group IProcedure/Surgery: normal saline In group II - patients underwent normal saline wash and bacterial load was noted. |
Who may qualify
- Ages
- 1 day to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- gastric, duodenal, ileal perforation, appendicitis
- those patients were willing to participate and the informed consent was taken
Key exclusion criteria (7 listed)
- evidence of enteric encephalopathy
- liver diseases
- renal diseases
- heart disease
- known allergy to any substance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Super Oxidized Solution in group IAlso: normal saline solutionTwo 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. | Procedure or surgery | Super Oxidized Solution, normal saline |
Primary outcome
the investigators measured the infection rate by checking the bacterial load during after surgery
Time frame: average of one year
The investigators asked about the infection, early recovery
1 secondary outcome
The Results Were Measured In the Form of the, Early Recovery, Early Bowel Sounds
Time frame: With in 10 -20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Peritonitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Super Oxidized Solution in group I in people with Peritonitis, run by Maharishi Markendeswar University (Deemed to be University).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the investigators measured the infection rate by checking the bacterial load during after surgery (time frame: average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016; AzTrials last refreshed its copy on 7 Nov 2026.