MITSU AB™ absorbable poly (glycolide/L-lactide) surgical suture U.S.P withantibacterial triclosan coating

Phase 4

Conditions: Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue

Registration Number: CTRI/2024/08/071764

Lead Sponsor: Meril Life Sciences Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Superficial Surgical site infection (SSI) <br/ ><br>2.Triclosan resistance of pathogens <br/ ><br>3.Bacterial selection and microscopic characterization <br/ ><br>4.Wound Healing GradeTimepoint: 1.Time Frame: Discharge, 7 days, 15 days, 30 postoperatively <br/ ><br>2.Time Frame: Discharge, 7 days, 15 days , 30 days post operation <br/ ><br>3.Time frame: Discharge, 7days, 15 days, 30 days post operation <br/ ><br>4.Time Frame: 7 days, 15 days, 30days

Secondary Outcome Measures

Name	Time	Method
1.Postoperative incisional pain score (Visual Analogue Scale or VAS) <br/ ><br>2.Re-admission due to SSI-related complications <br/ ><br>3.Re-intervention due to SSI-related complicationsTimepoint: 1. Time Frame: 7 days, 15 days, 30 days <br/ ><br>2.Time Frame: 7 days, 15 days, 30 days <br/ ><br>3.Time Frame: 7 days, 15 days, 30 days