| CTRI Number |
CTRI/2020/12/029925 [Registered on: 18/12/2020] Trial Registered Prospectively |
| Last Modified On: |
22/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study comparing two brands of similar suture materials (Trusynth Fast® and Vicryl Rapide®) for suturing after vaginal delivery |
|
Scientific Title of Study
|
Single blind, randomized comparative study assessing clinical equivalence of two polyglactin 910 fast absorbing suture brands, Trusynth Fast® and Vicryl Rapide®, on maternal morbidity experienced by women following episiotomy repair |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IND-HEALTHIUM-TRUSYNTH F-2020-11; V 2.0, Date: 20 April 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Kumar Moharana |
| Designation |
Chief Medical Officer |
| Affiliation |
Healthium Medtech Pvt.Ltd. |
| Address |
Healthium Medtech Pvt.Ltd.,
Clinical Affairs, 472D, 13th cross, 4th phase, Peenya Industrial Area
Bangalore
KARNATAKA
560058
India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar Moharana |
| Designation |
Chief Medical Officer |
| Affiliation |
Healthium Medtech Pvt.Ltd. |
| Address |
Healthium Medtech Pvt.Ltd., Clinical Affairs, 472D, 13th cross, 4th phase, Peenya Industrial Area
Bangalore
KARNATAKA
560058
India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar Moharana |
| Designation |
Chief Medical Officer |
| Affiliation |
Healthium Medtech Pvt.Ltd. |
| Address |
Healthium Medtech Pvt.Ltd., Clinical Affairs, 472D, 13th cross, 4th phase, Peenya Industrial Area
Bangalore
KARNATAKA
560058
India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
|
Source of Monetary or Material Support
|
| Healthium Medtech Pvt.Ltd., 472D, 13th cross, 4th phase, Peenya Industrial Area,
Bangalore KARNATAKA 560058 India |
|
|
Primary Sponsor
|
| Name |
Healthium Medtech Pvt Ltd |
| Address |
472D, 13th cross, 4th phase, Peenya Industrial Area,
Bangalore KARNATAKA 560058 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chethana Bolanthakodi |
Father Muller Medical College |
Department of OBG,
Father Muller Road, Kankanady, Mangalore – 575 002
Dakshina Kannada
KARNATAKA |
9901892381
bc3bhat@yahoo.co.in |
| Dr D Hemalatha Devi |
Government Victoria Hospital |
Department of OBG,
Town Hall St, Chengal Rao Peta, Port Area
Visakhapatnam
ANDHRA PRADESH |
9849903073
hema.vgh.gyn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee, Father Muller Research Center, Mangalore |
Approved |
| Institutional Ethics Committee, King George Hospital, Visakhapatnam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Trusynth Fast® Suture |
Trusynth Fast® Suture (Healthium) (Polyglactin 910 fast-absorbing suture; Suture will not be removed once
it is applied) |
| Comparator Agent |
Vicryl Rapide® Suture |
Vicryl Rapide® Suture (Johnson & Johnson) (Polyglactin 910 fast-absorbing suture; Suture will not be removed once it is applied) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Women aged 18-40 years, with a singleton pregnancy
2. Primiparous or multiparous women who will require episiotomy during the course of vaginal delivery
3. Women with gestational age of >34 weeks
4. Women with good systemic/ mental health as per opinion of investigator
5. Women who have given informed consent |
|
| ExclusionCriteria |
| Details |
1. Women with intrapartum fever and history of bleeding/coagulation disorders
2. Women having perineal tears, cervical tears, vaginal tears, extension of the episiotomies
3. Women who had a previous perineal surgery other than the primary repair after child birth
4. Women with known HIV or the hepatitis B infection
5. Women who has delivered a dead fetus
6. Women having any known allergy to the suture materials
7. Women already participating in another trial
8. Women unlikely to comply with study procedure or complete the scheduled follow up visit, in the opinion of investigator
9. Other indication-based exclusion, in the opinion of investigator |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Subjective assessment of perineal pain post episiotomy repair, with Trusynth Fast® and Vicryl Rapide® |
Day 2, Day 11, Week 6 and Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the use of analgesics in both the groups
2. To evaluate the wound healing in both the groups
3. To evaluate resumption of sexual activity and dyspareunia in both the groups
4. To assess overall intraoperative handling between two sutures
5. To evaluate no. of sutures utilized and residual suture removal in both the groups
6. To evaluate maternal morbidities post episiotomy |
Day 2, Day 11, Week 6 and Week 12 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Post Marketing Surveillance |
Date of First Enrollment (India)
Modification(s)
|
07/01/2021 |
| Date of Study Completion (India) |
14/07/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Episiotomy is a surgical incision of the perineum (the area between the vaginal opening and back passage) to enlarge the vaginal opening during labor or delivery. This procedure is done with scissors or scalpel and requires repair by suturing. Polyglactin 910 fast-absorbing sutures are commonly used for episiotomy repair as it is associated with less perineal pain, analgesic use, infection and re-suturing. In this study, we plan to assess differences in maternal morbidity between two commonly used brands of polyglactin 910 fast-absorbing sutures, Trusynth Fast® and Vicryl rapide®. |