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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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.


 
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