| CTRI Number |
CTRI/2025/07/090933 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Filaxyn AB(TM) is a sterile synthetic absorbable monofilament suture composed of Poly |
|
Scientific Title of Study
|
FILAXYN AB ABSORBABLE SUTURE: A prospective, observational, single-arm, open-label, multi-center, post-market clinical follow-up study to investigate the triclosan-resistant pathogenic colonization on the FILAXYN AB Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MES/FILAXYN AB ABSORBABLE SUTURE V1.0.0 dated 15-Feb-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near Bilakhia Stadium,Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India,Valsad
Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near Bilakhia Stadium,Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India,Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near Bilakhia Stadium,Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India,Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
|
Source of Monetary or Material Support
|
| Meril Endo-Surgery Pvt. Ltd.
Meril Park, E1-E3,
Survey No. 135/2/B and 174/2,
Muktanand Marg, Chala, Vapi,
Valsad, Gujarat– 396191 |
|
|
Primary Sponsor
|
| Name |
Meril Life Sciences Pvt Ltd |
| Address |
Near Bilakhia Stadium, Survey no 135/139,Muktanand marg, Chala, Vapi-396191, Gujarat, India |
| Type of Sponsor |
Other [Medical Device Company ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pushkar Galam |
Hope Hospital |
Omkar Plaza, GP-77, Thermax Chowk, near Shipra Hotel, Sambhajinagar, Chinchwad, Pune
Pune
MAHARASHTRA |
9970069146
drpushkargalam@gmail.com |
| Dr Yogesh M Desai |
Shanti Hospital and Prasuti Gruh |
Department of Gynecology, 1st floor, Udwada, Gujarat India-396185
Valsad
GUJARAT |
9825149603
shantihospital999@gmai.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dixit Hospital Institutional Ethics Committee |
Approved |
| Ojas Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who are willing to be treated with the FILAXYN AB™ Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P for use in general soft tissue approximation, including use in pediatric cardiovascular tissue and ophthalmic surgery (Other than contact with cornea and
sclera).
2. Subjects enroll both men and women and all general population adults of all age groups for soft tissue approximation and/or ligation.
3. Pediatric subjects with cardiovascular and ophthalmic surgery (other than contact with cornea and sclera).
4. Subjects must be willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form. In the case of a Subject and LAR being illiterate, a literate impartial witness is required during consenting.
5.The subject is not able to write on behalf of the Subject, the Subject’s LAR (Legally acceptable representative) can fill out the informed consent.
6. Subject is willing and able to comply with scheduled postoperative clinical evaluations. |
|
| ExclusionCriteria |
| Details |
1. Subjects who are not treated with the FILAXYN AB™ Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P.
2. Adult Subjects who require cardiovascular, microsurgery, and neurological tissue surgeries, FILAXYN AB™ Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P.
3. FILAXYN AB™ Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P cannot be used in direct contact with the heart,the central circulatory system, or the central nervous system.
4. Subjects who have known allergic reactions to Triclosan.
5. Pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Superficial Surgical site infection
2.Surgical Suture success
3.Adverse Events or Adverse Reactions or Complications
related to Suture |
1.Time Frame:
Through discharge, 7 days, 15 days, 1 month, 3 months
2.Time Frame: Through
discharge, 7 days, 15 days, 1 month, 3 months
3.Through discharge, 7
days, 15 days, 1 month, 3
months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Triclosan resistance to pathogens
2.Bacterial selection & microscopic characterization
3.Wound Healing Grade
4. Postoperative pain score
5. Re admission & Reoperation due to SSI related
complications
6. Ease of use |
Intra operative, Through discharge, 7 days, 15 days, 1 month, 3 month |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/07/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Study Name A prospective, observational, single-arm, open-label, multi-center,
post-market clinical follow-up study to investigate the triclosanresistant pathogenic colonization on the FILAXYN AB Absorbable
Poly(P-Dioxanone) Surgical Suture U.S.P.
Short Title FILAXYN AB ABSORBABLE SUTURE
Protocol ID, Version and Date
MES/FILAXYN AB ABSORBABLE SUTURE_Version 1.0.0_15-
Feb-2025
Study Device FILAXYN AB™ ABSORBABLE POLY(P-DIOXANONE)
SURGICAL SUTURE U.S.P
Rationale of the Study
An absorbable suture is a promising option when compared to non-absorbable sutures in terms of
reduced clinical time due to minimal postoperative visits and surgery site aesthetics. Absorbable
sutures are of fundamental importance in surgical outcomes. FILAXYN AB™ Absorbable
Poly(P-Dioxanone) Surgical Suture U.S.P is a sterile synthetic absorbable monofilament suture |