| CTRI Number |
CTRI/2020/06/025722 [Registered on: 09/06/2020] Trial Registered Prospectively |
| Last Modified On: |
30/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two skin antiseptics,
Chlorhexidine and Povidone-Iodine(Betadine) in women undergoing emergency cesarean delivery. |
|
Scientific Title of Study
|
Comparing the efficacy of Chlorhexidine Gluconate Versus Povidone-Iodine as Skin Antiseptic for prevention of Surgical Site Infection in women undergoing emergency Caesarean Delivery: A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gabbeta Spandana |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Obstetrics and Gynaecology,
AIIMS,Sijua,Patrapada,PO-Dumduma,Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8008186286 |
| Fax |
|
| Email |
gabbetaspandana94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pruthwiraj Sethi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Obstetrics and Gynaecology,
AIIMS,Sijua,Patrapada,PO-Dumduma,Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884132 |
| Fax |
|
| Email |
drpruthwiraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gabbeta Spandana |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Obstetrics and Gynaecology,
AIIMS,Sijua,Patrapada,PO-Dumduma,Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8008186286 |
| Fax |
|
| Email |
gabbetaspandana94@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Sijua, Patrapada,PO Dumduma, Bhubaneswar, Khordha district, Odisha, India.
PIN- 751019 |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
AIIMS, Sijua, Patrapada, PO-Dumduma, Bhubaneswar, Khordha District, Odisha, India.
Pincode- 751019. |
| 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 |
| Gabbeta Spandana |
All India Institute of Medical Sciences,Bhubaneswar |
Labor OT, Labor Room and NICU Complex, 2nd floor, AIIMS.
Khordha
ORISSA |
8008186286
gabbetaspandana94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O860||Infection of obstetric surgical wound, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chlorhexidine gluconate IP equivalent to 0.5% w/v of chlorhexidine gluconate and Isopropyl Alcohol 70% v/v purified water IP q.s. |
Skin preparation will be done by centrifugal scrubbing motion for 30 sec if incision site is dry and 2 min if incision site is moist starting from the area of the intended incision extending upward towards the sub-costal margin to the mid-axillary line and down to the middle of the thigh.The area will be then allowed to dry for 3 minutes.
|
| Comparator Agent |
Povidone iodine 10% w/v |
The povidone iodine application will be 2 step scrub followed by painting and then left to dry for 3 minutes before draping the area and commencing the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal women at ≥34 weeks gestational age
undergoing emergency Cesarean delivery
|
|
| ExclusionCriteria |
| Details |
1)Patients denying consent
2)Known allergy to one or both of the agents.
3)Patients with skin lesions adjacent to the operative site.
4)Women with chorioamnionitis, pyelonephritis, urinary tract infection, and mastitis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the incidence of surgical site infection with use of Chlorhexidinegluconate compared with povidone iodine as skin antiseptic in women undergoing emergency caesarean delivery. |
followed postoperatively after 48 hours,1 week and 30 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of the below outcomes
1)Duration of hospital stay.
2)Requirement for re-suturing.
3)Re-admission resulting from infection.
4)Pyrexia.
|
followed postoperatively after 48 hours, 1 week and 30 days. |
|
|
Target Sample Size
|
Total Sample Size="876"
Sample Size from India="876"
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 2 |
|
Date of First Enrollment (India)
|
15/06/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group, active controlled trial comparing the efficacy of chlorhexidine gluconate and povidone iodine as skin antiseptic for prevention of surgical site infection in women undergoing emergency caesarean delivery expecting chlorhexidine–gluconate to be superior to povidine iodine in having less incidence of SSI. The primary outcome measures will be the incidence of Surgical Site Infection. The secondary outcome measures will be the duration of hospital stay, requirement for re-suturing, re-admission resulting from infection, pyrexia.
|