| CTRI Number |
CTRI/2024/09/073911 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
08/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [EPISIOTOMY SUTURE MATERIALS] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial on three suture materials (Chromic catgut, Polyglactin 910, Polyglactin 910 Rapide) used in Episiotomy suturing and its outcomes. |
|
Scientific Title of Study
|
Outcomes of Episiotomy suturing using Chromic Catgut, Polyglactin 910,Polyglactin
910 Rapide sutures- A Triple – arm, Concurrent parallel Randomised Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NANDINI S |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AARUPADAI VEEDU MEDICAL COLLEGE,PONDICHERRY |
| Address |
Department of Obstetrics and Gynecology, A block, NO 22, Aarupadai veedu medical college and hospital, Puducherry Cuddalore main road,Kirumampakkam, Pondicherry
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9842304256 |
| Fax |
|
| Email |
nandinisenthilkumar25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SASIKALA R |
| Designation |
PROFESSOR |
| Affiliation |
AARUPADAI VEEDU MEDICAL COLLEGE,PONDICHERRY |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY,A BLOCK,NO 22,AARUPADAI VEEDU MEDICAL COLLEGE,PUDUCHERRY CUDDALORE MAIN ROAD,KIRUMAMPAKKAM,PONDICHERRY
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9443176240 |
| Fax |
|
| Email |
kalapani1955@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NANDINI S |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AARUPADAI VEEDU MEDICAL COLLEGE,PONDICHERRY |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY,A BLOCK,NO 22,AARUPADAI VEEDU MEDICAL COLLEGE,PONDICHERRY CUDDALORE MAIN ROAD,KIRUMAMPAKKAM,PONDICHERRY
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9842304256 |
| Fax |
|
| Email |
nandinisenthilkumar25@gmail.com |
|
|
Source of Monetary or Material Support
|
| AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL,PONDICHERRY CUDDALORE MAIN ROAD,KIRUMAMPAKKAM,PONDICHERRY 607402 |
|
|
Primary Sponsor
|
| Name |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY,A BLOCK,NO 22,AARUPADAI VEEDU MEDICAL COLLEGE,PONDICHERRY CUDDALORE MAIN ROAD,KIRUMAMPAKKAM,PONDICHERRY 607402 |
| 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 |
| NANDINI S |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY,NO22,AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL,PONDICHERRY CUDDALORE MAIN ROAD,KIRUMAMPAKKAM,PONDICHERRY 607402
Pondicherry
PONDICHERRY |
9842304256
nandinisenthilkumar25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICAL COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O901||Disruption of perineal obstetric wound, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CHROMIC CATGUT |
TENSILE STRENGTH IS 28 DAYS AND NO OF DAYS TAKEN FOR ABSORPTION IS 90 DAYS |
| Intervention |
POLYGLACTIN 910 |
TENSILE STRENGTH IS 4-5WEEKS AND NO OF DAYS TAKEN FOR ABSORPTION IS 56-70 DAYS |
| Intervention |
POLYGLACTIN 910 RAPIDE |
TENSILE STRENGTH IS 10-14 DAYS AND NO OF DAYS TAKEN FOR ABSORPTION IS 42 DAYS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ALL VAGINAL DELIVERIES UNDERGOING EPISIOTOMY |
|
| ExclusionCriteria |
| Details |
INFECTION (CHORIOAMNIONITIS) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of three absorbable suture materials - Chromic Catgut, Polyglactin 910,Polyglactin 910 Rapide sutures in terms of postoperative outcomes |
Day 1,Day 2,Day 3,2ND week,4TH week,3 months postnatally |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| POSTOPERATIVE PAIN,WOUND HEALING,SCARRING/FIBROSIS |
DAY1,DAY2,DAY3,2ND WEEK,4TH WEEK,3MONTHS POSTNATALLY |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2024 |
| 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="6"
Days="0" |
|
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
|
After getting IEC clearance from the institute and CTRI registration, informed and written consent from the patient who are willing to get enrolled in the study. Patients undergoing vaginal deliveries will be taken up for study based on inclusion and exclusion criteria. Patients having vaginal delivery with mediolateral episiotomy will be randomly allocated into 3 groups. Block randomization sequential allocation into blocks. Random sequence generation by random table prior to start of study. Group A (CHROMIC CATGUT), Group B (POLYGLACTIN 910), Group C (POLYGLACTIN 910 RAPIDE). All patients are sutured by same technique and by the same person. Same postoperative antibiotic and analgesic were given to all patients. Postoperative outcomes such as pain, healing, scarring/dyspareunia followed up on Day1,Day 2, Day 3,2nd week,4th week and 3 months postnatally. |