| CTRI Number |
CTRI/2026/03/106294 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [hydrogen peroxide,antiseptic agent] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A type of interventional study to see whether application of hydrogen p[eroxide prevents infection in participants post surgery |
|
Scientific Title of Study
|
A Prospective Randomised Controlled Clinical Trial For Effectiveness of Hydrogen Peroxide in Prevention Of SSI post Gynecological Surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARCHANA SINGH |
| Designation |
POST GRADUATE |
| Affiliation |
indira gandhi institute of medical sciences,patna |
| Address |
Department of Obstetrics and Gynaecology,Indira Gandhi Institute of Medical sciences,Sheikhpura,Patna
Patna
BIHAR
800014
India |
| Phone |
8804811888 |
| Fax |
|
| Email |
archisingh2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Neeru Goel |
| Designation |
professor and HOD |
| Affiliation |
indira gandhi institute of medical sciences,patna |
| Address |
Department of Obstetrics and Gynaecology,Room no-402,Indira Gandhi Institute Of Medical Sciences,Sheikhpura,Patna
Patna
BIHAR
800014
India |
| Phone |
9335118573 |
| Fax |
|
| Email |
goelneeru2004@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeru Goel |
| Designation |
Professor and HOD |
| Affiliation |
indira gandhi institute of medical sciences,patna |
| Address |
Room no-402,Department of Obstetrics and Gynaecology,IGIMS ,Sheikhpura
Patna
BIHAR
800014
India |
| Phone |
9335118573 |
| Fax |
|
| Email |
goelneeru2004@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ARCHANA SINGH |
| Address |
Department Of Obstetrics and Gynaecology,Sheikhpura,Patna |
| Type of Sponsor |
Other [MYSELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ARCHANA SINGH |
Indira Gandhi Institute Of Medical Sciences |
Department Of Obstetrics and Gynaecology
Patna
BIHAR |
8804811888
archisingh2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N930||Postcoital and contact bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
OTHER THAN HYDROGEN PEROXIDE |
ANYTHING BEFORE CLOSING WOUND BUT NOT HYDROGEN PEROXIDE |
| Intervention |
USE OF HYDROGEN PEROXIDE |
HYDROGEN PEROXIDE TO PREVENT INFECTION |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
all females coming for gynecological surgeries at igims patna |
|
| ExclusionCriteria |
| Details |
all patients not giving consent,
patient having comorbities like anemia,hypertension and cardiovascular d/s |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence Of Surgical Site Infection in patients undergoing gynaecological surgery with hydrogen peroxide irrigation |
within 30 days after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of wound gaping, post operative febrile morbidity, need for restoring,requirement of antibiotics |
within 30 days of surgery |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ALL THE PATIENTS UNDERGOING GYNECOLOGICAL SURGERIES ARE ALLOCATED AS CASES AND CONTROL AND HYDROGEN PEROXIDE IS APPLIED TO CASSES TO SEE SURGICAL SITE INFECTUON AND THEN INCIDENCE OF SURGICAL SITE INFECTION AND RROLE OF HYDROGEN PEROXIDE IN PREVENTING IT IS STUDIED. |