| CTRI Number |
CTRI/2024/08/071764 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
MITSU ABâ„¢ absorbable poly (glycolide/L-lactide) surgical suture U.S.P with
antibacterial triclosan coating |
Scientific Title of Study
Modification(s)
|
A prospective, single-arm, multicenter, observational post-marketing surveillance study to investigate the triclosan-resistant pathogenic colonization on MITSU ABâ„¢ absorbable poly (glycolide/L-lactide) triclosan- coated surgical suture U.S.P after soft tissue approximation in a real-world setting |
| Trial Acronym |
MITSU AB |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MES/ MITSU AB Absorbable Suture V2.0.0 01-Oct-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirankumar Shetty |
| Designation |
Senior Manager- Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
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
Scientific Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
Senior Manager- Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no
135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
Senior Manager- Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no
135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
|
Source of Monetary or Material Support
|
| Meril Endo Surgery Pvt. Ltd. E1-E3 Meril Park, Survey No. 135/2/B and 174/2, Muktanand Marg, Chala Vapi–396191, Gujarat, India
|
|
|
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 General Surgery, Omkar Plaza, , Near Axis Bank,/ Shipra HotelBank Sambhaji Nagar, Tharmax, Chowk, Chinchwad, Pune, Maharashtra 411019
Pune
MAHARASHTRA |
9970069146
drpushkargalam@gmail.com |
| Dr Yogesh M Desai |
Shanti Hospital and Prasuti Gruh |
1st Floor, Department of Gynecology, Udwada, Gujarat India-396185
Valsad
GUJARAT |
9825149603
shantihospital999@gmai.com |
| Dr Anand Tank |
Swaminarayan Mandir Vasna Sanstha-SMVS hospital |
general and laparoscopic surgeon, Ground Floor
Gandhinagar - Ahmedabad Rd, beside Swaminarayan Dham, Randesan, Gandhinagar, Gujarat 382007
Gandhinagar
GUJARAT |
9913185264
tankanand84@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Dixit Hospital Institutional Ethics Committee |
Approved |
| IEC SMVS Swaminarayan Hospital |
Approved |
| Ojas Multispeciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
5.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All consecutive patients who will undergo general soft tissue approximation and or ligation except for ophthalmic, cardiovascular, and neurological tissues.
2. The Subject must be treated with MITSU AB.
3. The Subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form.
4. In the case of a Subject and LAR being illiterate a literate impartial witness is required during consenting.
5. If the Subject is not able to write on behalf of the Subject, the Subjects LAR can fill out the informed consent.
6. The Subject is willing and able to comply with postoperative scheduled clinical evaluations.
7. Subjects who are able to give voluntary written informed consent to participate in this clinical investigation and from whom consent has been obtained
8. Women who have undergone a Cesarean section and received sutures |
|
| ExclusionCriteria |
| Details |
1. The Subject who does not approve the informed consent is not eligible for the study.
2. MITSU AB absorbable suture is not recommended where an extended approximation of tissues under stress is required.
3. MITSU AB absorbable suture should not be used in patients having any known sensitivity to suture material, i.e., glycolide, L-lactide, calcium stearate, and triclosan.
4. Subjects who require surgeries of either ophthalmic, cardiovascular, or central nervous system are not considered for MITSU AB absorbable suture.
5. Any Subject with an immune compromised medical condition shall not be considered.
6. The pregnant women shall be excluded.
|
|
|
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 (SSI)
2.Triclosan resistance of pathogens
3.Bacterial selection and microscopic characterization
4.Wound Healing Grade |
1.Time Frame: Discharge, 7 days, 15 days, 30 postoperatively
2.Time Frame: Discharge, 7 days, 15 days , 30 days post operation
3.Time frame: Discharge, 7days, 15 days, 30 days post operation
4.Time Frame: 7 days, 15 days, 30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Postoperative incisional pain score (Visual Analogue Scale or VAS)
2.Re-admission due to SSI-related complications
3.Re-intervention due to SSI-related complications |
1. Time Frame: 7 days, 15 days, 30 days
2.Time Frame: 7 days, 15 days, 30 days
3.Time Frame: 7 days, 15 days, 30 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/08/2024 |
| Date of Study Completion (India) |
25/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
MITSU AB Absorbable Suture: A prospective, single-arm, multicenter, observational post-marketing surveillance study to investigate the triclosan-resistant pathogenic colonization on MITSU ABâ„¢ absorbable poly (glycolide/L-lactide) triclosan- coated surgical suture U.S.P after soft tissue approximation in a real-world setting
Protocol Number: MES/ MITSU AB Absorbable Suture
Protocol Version: Version 2.0.0 Issue date: 01-Oct-2024
Study Device: MITSU ABâ„¢ absorbable poly (glycolide/L-lactide) surgicalsuture U.S.P with antibacterial triclosan coating
Indication: MITSU ABâ„¢ absorbable suture is indicated for use in general soft tissue approximation and/or ligation except for ophthalmic, cardiovascular, and neurological tissues.
Objective: The study aims to investigate the triclosan-resistant pathogenic colonization on MITSU ABâ„¢ absorbable poly (glycolide/L-lactide) surgical suture U.S.P in a realworld setting.
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. MITSU ABâ„¢ is a copolymer (90% glycolide and 10% L-lactide) suture layered with triclosan, an antibacterial agent. Despite the presence of an antibiotic, there is a putative possibility of SSI due to triclosan-resistant pathogens. Hence, the present study is to investigate the triclosan-resistant pathogenic colonization on MITSU ABâ„¢ absorbable poly (glycolide/L-lactide) surgical suture U.S.P in a real-world setting after the fixation of soft tissue approximation wherein use of absorbable suture is appropriate. |