| CTRI Number |
CTRI/2025/07/092029 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
FILAPRON AB(TM) is a sterile synthetic absorbable monofilament suture composed of poly (glycolide-co-caprolactone). |
|
Scientific Title of Study
|
A prospective, single-arm, open-label, multi-centre, observational, post-market clinical follow-up study to investigate the triclosan-resistant pathogenic colonization on FILAPRON AB(TM) Absorbable Poly (glycolide-co-caprolactone) Surgical Suture U.S.P in a real-world setting. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MES/FILAPRON AB ABSORBABLE SUTURE V1.0.0 dated 15.02.25 |
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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pushkar Galam |
Hope Hospital |
1st floor, Department of Laproscopy ,Omkar Plaza, GP-77, Thermax Chowk, near Shipra Hotel, Sambhajinagar, Chinchwad, Pune
Pune
MAHARASHTRA |
9970069146
drpushkargalam@gmail.com |
| Dr Hezan Zaveri |
Shah Nursing Home |
Department of General Surgery, Ground Floor,Zanda Chowk, Udwada, Gujarat India-396185
Valsad
GUJARAT |
8980664448
hezanzaveri@gmail.com |
| Dr Yogesh M Desai |
Shanti Hospital and Prasuti Gruh |
1st Floor, Department of Gynecology, Udwada, Gujarat India-396185
Valsad
GUJARAT |
9825149603
yogidesai89@yahoo.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 |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who will undergo general soft tissue
approximation and /or ligation.
2.Subject who undergoing treatment of FILAPRON AB(TM) suture.
3.Subject is 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.
4.Subject is not able to write on behalf of the Subject, the Subject’s LAR (Legally acceptable representative) can fill out the informed consent.
5.Subject is willing and able to comply with postoperative scheduled clinical evaluations.
6.Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained.
|
|
| ExclusionCriteria |
| Details |
1.Subject who does not able to provide the written informed consent form.
2.Subject for whom absorbable sutures are not recommended or suitable should avoid their use in situations requiring prolonged tissue approximation under stress.
3.FILAPRON AB™ absorbable suture must not be used for abdominal or facial tissue closure.
4.Subjects with known sensitivity to suture material, i.e., glycolide, caprolactone, and triclosan.
5.Subjects who require surgeries of either ophthalmic, cardiovascular, or central nervous system.
6.Subject with an immune compromised medical condition.
7. Pregnant women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Surgical site infection
2.Adverse events
3.Success rate |
1.Time Frame: 7 days, 15days, 30 days and 4 months
2.Time Frame: Through Discharge, 7 days, 15 days, 30 days and 4 months
3.Time Frame: Intra operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Triclosan resistance of pathogens
2.Bacterial selection & microscopic characterization
3.Incisional pain
4.Re admission & Re intervention due to related complications
5.Intra operative suture handling
6.Wound cosmesis |
1.Time Frame: Discharge, 7
days, 15 days, 30 days & 4 months post operation
2.Time frame: Discharge, 7 days, 15 days, 30 days & 4 months post operation
3.Time frame: Discharge, 7 days, 15 days, 30 days & 4 months post operation
4.Time Frame: 7 days, 15 days, 30 days & 4 months
5.Time Frame: Intraoperative
6.Time Frame: Discharge, 7 days, 15 days, 30 days & 4 months |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
31/08/2025 |
| 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="4"
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, single-arm, open-label, multi-centre, observational,
post-market clinical follow-up study to investigate the triclosanresistant pathogenic colonization on FILAPRON AB™ Absorbable
Poly (glycolide-co-caprolactone) Surgical Suture U.S.P in a realworld setting.
Short Title: FILAPRON AB ABSORBABLE SUTURE
Protocol ID, Version &
Date:
MES/FILAPRON AB ABSORBABLE SUTURE_Version
1.0.0_15-Feb-2025
Study Device: FILAPRON AB™ Absorbable Poly (glycolide-co-caprolactone)
Surgical Suture U.S.P.
Indication: FILAPRON AB™ sutures are intended for use in general soft tissue
approximation and /or ligation where an absorbable material is
indicated but not for use in cardiovascular or neurological tissues or
ophthalmic surgery.
Objective: This study aims to investigate the triclosan-resistant pathogenic
colonization on FILAPRON AB™ Absorbable Poly (glycolide-cocaprolactone) Surgical Suture U.S.P in real-world settings.
Study Population: The study includes Subjects who require FILAPRON AB™
Absorbable Poly (glycolide-co-caprolactone) Surgical Sutures for
approximation and /or ligation of general soft tissues except for
cardiovascular, neurological tissues or ophthalmic surgery.
Study Design: A prospective, single-arm, open-label, multi-centre, observational,
post-market clinical follow-up study.
Rationale of the Study: The selection of suture material is crucial for ensuring effective tissue approximation and
optimal wound healing while minimizing complications such as scarring, ischemia, and tissue
damage. Surgeons need to carefully choose a suture based on factors like the tissue type,
required strength, and the duration of support needed. Absorbable sutures break down in the
body over time due to hydrolysis or enzymatic activity. They are commonly used for internal
tissues where removal is not possible. FILAPRON AB™ is a sterile, non-pyrogenic, synthetic
absorbable monofilament suture composed of poly (glycolide-co-caprolactone) and coated with
triclosan. FILAPRON AB™ sutures are intended for use in general soft tissue approximation and
/or ligation where an absorbable material is indicated but not for use in cardiovascular or
neurological tissues or ophthalmic surgery. Despite antibiotic treatment, there remains a potential
risk of SSI due to pathogens resistant to triclosan. Therefore, the current study is to investigate
the triclosan-resistant pathogenic colonization on FILAPRON AB™ absorbable poly (glycolideco-caprolactone) surgical suture U.S.P in a real-world setting after the fixation of soft tissue
approximation. |