| CTRI Number |
CTRI/2021/12/038632 [Registered on: 15/12/2021] Trial Registered Prospectively |
| Last Modified On: |
22/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [povidone iodine vs normal saline] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
SURGICAL SITE INFECTION FOLLOWING WOUND IRRIGATION WITH POVIDONE-IODINE VS NORMAL SALINE |
|
Scientific Title of Study
|
SURGICAL SITE INFECTION FOLLOWING WOUND IRRIGATION WITH POVIDONE-IODINE VS NORMAL SALINE BEFORE SKIN CLOSURE IN CAESAREAN SECTIONS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohan Sodhi |
| Designation |
junior resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Obstetrics and Gynaecology, PGIMER
Chandigarh
CHANDIGARH
150012
India |
| Phone |
8800468046 |
| Fax |
|
| Email |
rohansodhi94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Minakshi rohilla |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Obstetrics and Gynaecology, PGIMER
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9914209354 |
| Fax |
|
| Email |
minurohilla@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohan Sodhi |
| Designation |
junior resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Obstetrics and Gynaecology, PGIMER
Chandigarh
CHANDIGARH
150012
India |
| Phone |
8800468046 |
| Fax |
|
| Email |
rohansodhi94@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
PGIMER Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rohan Sodhi |
PGIMER |
Clean labour room, block D, level 3, nehru hospital, pgimer, chandigarh
Chandigarh
CHANDIGARH |
8800468046
rohansodhi94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
wound irrigation before skin closure in caesarean section |
wound irrigation will be done with normal saline ( 0.9%)
before skin closure during caesarean sections, will be done only once |
| Intervention |
wound irrigation before skin closure in caesarean section |
wound irrigation will be done with povidone-iodine (5%) before skin closure in caesarean section, will be done only once |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
All emergency and elective caesarean sections |
|
| ExclusionCriteria |
| Details |
on immunosuppressant drugs
suspected or known allergy to iodine
class III or class IV wound
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study incidence of SSI in elective and emergency caesarean section undergoing wound irrigation with povidone-iodine or normal saline |
to study incidence of SSI in elective and emergency caesarean section undergoing wound irrigation with povidone-iodine or normal saline
assessment for SSI will be done at day 7 post op, 2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to study incidence of culture positive SSI in elective and emergency caesarean section
to measure incidence of specific organism cultured in SSI in elective and emergency caesarean |
to study incidence of culture positive SSI in elective and emergency caesarean section
to measure incidence of specific organism cultured in SSI in elective and emergency caesarean . Assessment will be done at day 7 postop, 2wks postop and 4 weeks postop |
|
|
Target Sample Size
|
Total Sample Size="476"
Sample Size from India="476"
Final Enrollment numbers achieved (Total)= "609"
Final Enrollment numbers achieved (India)="609" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2021 |
| Date of Study Completion (India) |
08/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To assess the incidence of SSI in women following wound irrigation with povidone iodine vs normal saline before skin closure in caesarean sections |