| CTRI Number |
CTRI/2020/06/026040 [Registered on: 22/06/2020] 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 Trial |
|
Public Title of Study
|
A study comparing two brands of similar suture materials (Truglyde Fast® or Safil Quick®) for suturing after vaginal delivery |
|
Scientific Title of Study
|
Single blind, randomized comparative study assessing clinical equivalence of two polyglycolic acid fast absorbing suture brands, Truglyde Fast® and Safil Quick®, on maternal morbidity experienced by women following episiotomy repair |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IND-HEALTHIUM-TRUGLYDE F-2020-09; V 2.0; Date:18 May 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., 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., 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., 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 |
Healthium Medtech Pvt.Ltd., 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
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Roopa N K |
BGS Global Institute of Medical Sciences & Hospital |
Department of OBG, BGS Global Institute of Medical Sciences & Hospital,
No. 67, BGS Health & Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
9880715085
srikanthroopa@yahoo.com |
| Dr Y Aruna Subha Shree Rao |
King George Hospital, Visakhapatnam |
Department of Obstetrics & Gynaecology, Maharani Peta, Viskhaptanam-530002
Visakhapatnam
ANDHRA PRADESH |
9866655515
arunay67@hotmail.com |
| Dr Gitanjali Devgarha |
Marudhar Hospital |
Department of OBG, Marudhar Hospita, A 93-99, Singh Bhoomi, Khatipur
Jaipur
RAJASTHAN |
9414287892
gdevgarha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences & Hospital, Bengaluru |
Approved |
| Institutional Ethics Committee, King George Hospital, Visakhapatnam |
Approved |
| Marudhar Hospital Ethics Committee, Jaipur |
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 |
| Comparator Agent |
Safil Quick Suture® |
Safil Quick Suture® (B. Braun) (Polyglycolic acid fast-absorbing suture; Suture will not be removed once it is
applied) |
| Intervention |
Truglyde Fast Suture® |
Truglyde Fast Suture® (Healthium) (Polyglycolic acid 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 Truglyde Fast® and Safil Quick® |
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)
|
09/08/2020 |
| Date of Study Completion (India) |
29/03/2021 |
| 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)?
|
|
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. Polyglycolic acid 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 polyglycolic acid fast-absorbing sutures, Truglyde Fast® and Safil Quick®.
|