| CTRI Number |
CTRI/2024/12/077587 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [SUTURES FOR SKIN CLOSURE ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Sutures for skin closure in caesarean section |
|
Scientific Title of Study
|
Subcuticular skin closure in Caesarean section polyglactin-910 (Vicaryl Rapid) versus poliglecaprone-25 (Monocryl) – A randomised control trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| drharpreet@ |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harpreet Kaur |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor, All India Institute of Medical Sciences, Bilaspur, Himachal Pradesh, India |
| Address |
Department of Obstetrics and Gynaecology,
All India Institute of Medical Sciences, Bilaspur, Himachal Pradesh, India
Bilaspur
HIMACHAL PRADESH
174001
India |
| Phone |
9872221818 |
| Fax |
|
| Email |
drharpreetsidhu7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harpreet Kaur |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor, All India Institute of Medical Sciences, Bilaspur, Himachal Pradesh, India |
| Address |
Department of Obstetrics and Gynaecology,
All India Institute of Medical Sciences, Bilaspur, Himachal Pradesh, India
Bilaspur
HIMACHAL PRADESH
174001
India |
| Phone |
9872221818 |
| Fax |
|
| Email |
drharpreetsidhu7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harpreet Kaur |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor, All India Institute of Medical Sciences, Bilaspur, Himachal Pradesh, India |
| Address |
Department of Obstetrics and Gynaecology,
AIIMS, Bilaspur, Himachal Pradesh
India
Bilaspur
HIMACHAL PRADESH
174001
India |
| Phone |
9872221818 |
| Fax |
|
| Email |
drharpreetsidhu7@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Associate Professor AIIMS Bilaspur |
| Address |
All India Institute of Medical Sciences, Bilaspur, Himachal Pradesh. India
PIN- 174001
e-mail: dr.harpreet.obg@aiimsbilaspur.edu.in
Phone: 9872221818 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Harpreet Kaur |
All India Institute of Medical Sciences, Bilaspur, Himachal Pradesh, India |
Department of Obstetrics and Gynecology
Bilaspur
HIMACHAL PRADESH |
9872221818
drharpreetsidhu7@gmail.com |
| Dr Nidhi Jindal |
IGMC, SHIMLA |
Department of Obstetrics and Gynaecology
Shimla
HIMACHAL PRADESH |
8894334438
docnidhi20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTE (BIOMEDICAL AND HEALTH RESEARCH), AIIMS BILASPUR |
Approved |
| INSTITUTE ETHICS COMMITTE, IGMC, Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O754||Other complications of obstetric surgery and procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
subcuticular skin closure with Poliglecaprone 25 (Monocryl, Ethicon) suture number 3-0 |
All women satisfying the inclusion and exclusion criteria and requiring LSCS for various indications will undergo a thorough evaluation AND
subcuticular skin closure with Poliglecaprone 25 (Monocryl, Ethicon) suture number 3-0 will be done |
| Intervention |
Subcuticular skin closure with Polyglactin 910 (Vicryl Rapide) suture number 2-0 IN women UNDERGOING LSCS |
All women satisfying the inclusion and exclusion criteria and requiring LSCS for various indications will undergo a thorough evaluation AND
Subcuticular skin closure with Polyglactin 910 (Vicryl Rapide) suture number 2-0 WILL BE DONE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Women aged 18-40 years
2. undergoing LSCS for various indications in the labour ward of Obstetrics & gynaecology, AIIMS, Bilaspur (H.P.) & IGMC Shimla during the study period |
|
| ExclusionCriteria |
| Details |
1. Obesity - booking BMI >30
2. Vertical skin incision
3. Previous vertical abdominal scar
4. Any signs/symptoms suggestive of infection like chorioamnionitis, fever or UTI in the last 2 weeks,
5. Women on systemic steroids/ immune compromised
6. Local skin lesions/ infections
7. Haemodynamically unstable patient
8. Women with GDM/pre-gestation DM on insulin
9. Chronic renal disease, inflammatory bowel disease
10. Preterm LSCS (<36 weeks POG)
11. Anaemia with Hb <9.0 gm%
12. Multiple pregnancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| composite wound complications defined as per CDC guidelines as: surgical site infection (culture-positive SSI), wound haematoma or seroma (defined as at least moderate serous fluid collection or subcutaneous blood collection) or wound dehiscence (wound separation of 1 cm or more in length) within 30 days following LSCS |
within 30 days following LSCS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Post-operative pain: assessed by Visual Analogue Scale (VAS) (12)on day 1 and day 2 post-operative. ( |
day 1 and day 2 post-op |
| 2. Cosmetic Outcome: assessed by patient satisfaction and observer assessment at 6 weeks post-operative, and the presence of a hypertrophic and hyperpigmented scar anytime till 6 weeks post-operative. (will be assessed by Patient Scar Assessment Scale (PSOAS) and Observer Scar Assessment Scale |
6 weeks post-op |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
14/12/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response (Others) - TO BE DECIDED
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 13-11-2025 and end date provided 13-05-2026?
Response (Others) - ON REQUEST
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
Caesarean section contributes to a significant number of deliveries worldwide. The risk of wound complications following CS varies from 3 %- 30%. Several suture materials have been used to aid the physiological wound healing and skin approximation after CS. An ideal skin suture should be safe, lead to good wound healing, have a cosmetically acceptable scar with minimal patient discomfort, and be free from wound complications. Various studies have compared sutures with staplers, different types of absorbable suture materials in subcuticular closure and absorbable with non-absorbable suture materials. We intend to study the composite wound complication rate and the patient satisfaction rate of two different suture materials in subcuticular skin closure. Poliglecaprone 25 (Monocryl, Ethicon) is a routinely used suture for skin closure in our set-up, and we wish to compare the same with the Polyglactin 910 (Vicryl Rapid), which is an easily available, cheap and rapidly absorbable suture material mostly used in skin closure for episiotomy repair.
|