| CTRI Number |
CTRI/2019/10/021735 [Registered on: 22/10/2019] Trial Registered Prospectively |
| Last Modified On: |
19/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of vaginal cleansing with Povidone Iodine solution on post operative infection rates |
|
Scientific Title of Study
|
Effect of pre-operative vaginal preparation with Povidone Iodine before abdominal hysterectomy at AIIMS Rishikesh: A Randomised Controlled Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Jaya Chaturvedi |
| Designation |
Head of department |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Obstetrics and Gynaecology, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9997310120 |
| Fax |
|
| Email |
jaya_sunil@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Jaya Chaturvedi |
| Designation |
Head of department |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Obstetrics and gynaecology, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9997310120 |
| Fax |
|
| Email |
jaya_sunil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shagun Tiwari |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Obstetrics and gynecology, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
7497917226 |
| Fax |
|
| Email |
drvidushitiwari@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh |
| 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 |
| shagun tiwari |
AIIMS Rishikesh |
Department of Obstetrics and gynaecology, AIIMS Rishikesh
Dehradun
UTTARANCHAL |
7497917226
drvidushitiwari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N925||Other specified irregular menstruation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
vaginal preparation with povidone iodine |
preoperative vaginal preparation with 5% povidone iodine solution |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
reproductive age females |
|
| ExclusionCriteria |
| Details |
1.Patients undergoing vaginal hysterectomy
2.Patients undergoing laparoscopic hysterectomy
3Patients undergoing emergency hysterectomy
4.Patients undergoing obstetric hysterectomy
5.Patients allergic to iodine containing solutions.
6.Patients undergoing hysterectomies for malignant indications.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post operative infections |
48 hours, 8 days,4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparing the types of post operative infections in two groups |
day 2, 8, 4 weeks post op |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 1 |
|
Date of First Enrollment (India)
|
25/10/2019 |
| 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="0"
Months="1"
Days="0" |
|
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
|
To study the effect of vaginal preparation on post operative infectious morbidity to determine its usefulness considering the practice of omitting this practice at many centres including our institute due to lack of sufficient evidences supporting this routine |