| CTRI Number |
CTRI/2026/03/106284 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
25/08/2026 |
| 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 of two antibiotic coated sutures |
|
Scientific Title of Study
|
A Prospective, Single-Blind, Multicenter, Randomized Controlled Study to Evaluate the Clinical Equivalence of two Triclosan-Coated Polyglactin 910 Sutures, Trusynth Plus Neo and Vicryl Plus in Caesarean Section Wound Closure |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-CE-TCS-2026 Dated 28 Jan 2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Moharana |
| Designation |
Chief Medical Officer |
| Affiliation |
Healthium Medtech Ltd |
| Address |
472D, 13th cross, 4th phase, Peenya Industrial Area, Bangalore
Bangalore KARNATAKA 560058 India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashok Moharana |
| Designation |
Chief Medical Officer |
| Affiliation |
Healthium Medtech Ltd |
| Address |
472D, 13th cross, 4th phase, Peenya Industrial Area, Bangalore
Bangalore KARNATAKA 560058 India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ashok Moharana |
| Designation |
Chief Medical Officer |
| Affiliation |
Healthium Medtech Ltd |
| Address |
472D, 13th cross, 4th phase, Peenya Industrial Area, Bangalore
Bangalore KARNATAKA 560058 India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
|
Source of Monetary or Material Support
|
| Healthium Medtech Ltd. 472/D, 13th cross, 4th phase, Peenya Industrial Area, Bengaluru-560058 |
|
|
Primary Sponsor
|
| Name |
Healthium Medtech Ltd. |
| Address |
472/D, 13th cross, 4th phase, Peenya Industrial Area, Bengaluru-560058 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepthy Balakrishnan |
All India Institute of Medical Sciences (AIIMS), Bhubaneswar |
Department of Obstertrics and Gynaecology, Sijua, Post: Dumuduma,
Patrapada, Bhubaneswar,
Odisha - 751019 Khordha ORISSA |
9446439373
Obgyn_deepthy@aiimsbhubaneswar.edu.in |
| Dr Ashok Kumar Devoor |
Bangalore Medical College and Research Institute |
5th floor, HRP Block, Vanivilas Hospital, Fort Road, Bangalore-560002 Bangalore KARNATAKA |
9964195445
drashok2008@rediffmail.com |
| Dr Runa Bal |
NRS Medical College and Hospital |
3rd Floor, Department of Gynaecology and Obstetrics, NRS Medical College and Hospital, 138, AJC Bose, Kolkata- 700014 Kolkata WEST BENGAL |
9830155463
drrunabal@gmail.com |
| Dr Ashish Rambhau Kubde |
Seven Star Hospital |
Room No 1, 2nd Floor, Department of OBG, 324/1, Jagnade Square, Great Nag Road Nagpur MAHARASHTRA |
9373103487
ashishkubde@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics committee of BMCRI |
Approved |
| Ethics Committee Rahate Surgical Hospital |
Approved |
| Institutional Ethics Committee, AIIMS, Bhubaneswar |
Approved |
| Nil Ratan Sircar Medical College Institutional Ethics Committee |
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 |
| Intervention |
Trusynth Plus Neo suture |
Triclosan-Coated Polyglactin 910 Suture; Manufactured by Healthium Medtech Limited. Once implanted, the suture will not be removed from body. |
| Comparator Agent |
Vicryl Plus Suture |
Triclosan-Coated Polyglactin 910 Suture; Manufactured by Ethicon, Johnson and Johnson. Once implanted, the suture will not be removed from body. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women aged 18 to 40 years scheduled to undergo caesarean section delivery using a Pfannenstiel incision
2. Pregnant women who have given written informed consent |
|
| ExclusionCriteria |
| Details |
1. Pregnant women with haemoglobin levels less than 7g/dL
2. Pregnant women with active systemic infection or sepsis, or receiving therapeutic antibiotics other than standard perioperative prophylaxis
3. Pregnant women with known HIV infection
4. Pregnant women with a known allergy or hypersensitivity to triclosan and/or polyglactin 910 sutures
5. Pregnant women requiring additional major surgical procedures at the time of caesarean section
6. Pregnant women receiving chronic systemic corticosteroids, immunosuppressive therapy, or other medications known to impair wound healing
7. Pregnant women with known bleeding or coagulation disorders
8. Pregnant women diagnosed with placenta accreta spectrum (PAS) disorders
9. Pregnant women with intrauterine foetal demise (stillbirth)
10. Pregnant women who, in the opinion of the investigator, are unlikely to comply with the study procedures or complete scheduled follow-up visits
11. Any condition which, in the opinion of the investigator, may compromise trial participant’s safety or affect study integrity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate the clinical equivalence between Trusynth Plus Neo and Vicryl Plus sutures in caesarean section wound closure, as assessed by the change in ASEPSIS wound score from Day 3 post-surgery (Day 3 ± 1 day) to Day 30 post-surgery (Day 30 ± 7 days) |
Visit 3 (Day 3 ± 1), Visit 5 (Day 30± 7) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative wound condition between Trusynth Plus Neo and Vicryl Plus sutures following caesarean section, as assessed by the change in ASEPSIS wound score from Day 3 post-surgery (Day 3 ± 1 day) to Day 14 (± 3 days), Day 30 (± 7 days), and Day 90 (± 7 days) post-surgery |
Visit 3 (Day 3 ± 1), Visit 4 (Day 14± 3), Visit 5 (Day 30± 7), Visit 6 (Day 90± 7) |
| To compare the operative time between Trusynth Plus Neo and Vicryl Plus suture groups |
Visit 2 (Day of Surgery) |
| To compare the intra-operative suture handling and needle characteristics between Trusynth Plus Neo and Vicryl Plus suture groups |
Visit 2 (Day of Surgery) |
| To compare the intra-operative complications between Trusynth Plus Neo and Vicryl Plus suture groups |
Visit 2 (Day of Surgery) |
| To compare the incidence of post-operative complications, including surgical site infection and other wound-related complications, between Trusynth Plus Neo and Vicryl Plus suture groups |
Visit 3 (Day 3 ± 1), Visit 4 (Day 14±3), Visit 5 (Day 30± 7), Visit 6 (Day 90± 7) |
| To compare the length of hospital stay between Trusynth Plus Neo and Vicryl Plus suture groups |
Visit 4 (to collect the date of discharge) |
| To compare the postoperative pain intensity between Trusynth Plus Neo and Vicryl Plus suture groups |
Visit 3 (Day 3± 1), Visit 4 (Day 14± 3), Visit 5 (Day 30± 7), Visit 6 (Day 90± 7) |
| To compare postoperative activities of daily living between the Trusynth Plus Neo and Vicryl Plus suture groups |
Visit 3 (Day 3 ± 1), Visit 4 (Day 14± 3), Visit 5 (Day 30± 7), Visit 6 (Day 90± 7) |
| To compare the incidence of residual risks, adverse events (AEs) and serious adverse events (SAEs) between Trusynth Plus Neo and Vicryl Plus suture groups |
Visit 2 (Day of surgery), Visit 3 (Day 3 ± 1), Visit 4 (Day 14± 3), Visit 5 (Day 30± 7), Visit 6 (Day 90± 7) |
| To compare the cosmetic appearance of the resultant surgical scar following caesarean section between Trusynth Plus Neo and Vicryl Plus suture groups |
Visit 5 (Day 30± 7), Visit 6 (Day 90± 7) |
|
|
Target Sample Size
|
Total Sample Size="160" Sample Size from India="160"
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 4 |
|
Date of First Enrollment (India)
|
25/03/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Surgical site infections (SSIs) are a common and serious healthcare-associated infection that increase morbidity, hospital stay, costs, and patient dissatisfaction, and they remain a significant concern following caesarean section (CS), the most frequently performed abdominal surgery worldwide. SSI rates after CS range from 2–10%, with superficial, deep, and organ/space infections contributing to delayed recovery, readmission, reoperation, and long-term morbidity. While SSIs are multifactorial in origin, surgical sutures play a key role because they are foreign materials placed directly in the wound and can act as a nidus for bacterial colonization, particularly at suture knots. Appropriate suture selection depends on biological compatibility, mechanical performance, wound tension, tissue characteristics, and handling properties, all of which influence wound healing and infection risk. To reduce bacterial colonization, antibacterial-coated sutures have been developed, most notably triclosan-coated sutures. Triclosan is a broad-spectrum antibacterial agent effective against common SSI pathogens, with proven in vitro, in vivo, and clinical evidence showing reduced bacterial adhesion and lower SSI rates. Based on this evidence, both the World Health Organization and the National Institute for Health and Care Excellence recommend the use of triclosan-coated sutures to reduce the risk of SSIs. Vicryl Plus Triclosan-Coated Polyglactin 910 sutures have been widely utilized in caesarean section wound closure. To further expand available treatment options, it is important to demonstrate that other triclosan coated polyglactin 910 sutures, such as Trusynth Plus Neo, can deliver equivalent outcomes. Thus, this study is designed to compare the clinical equivalence of Trusynth Plus Neo (triclosan coated polyglactin 910 suture) with Vicryl Plus (triclosan coated polyglactin 910 suture) in caesarean section wound closure. |