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SUTURE PMCF STUDY(Sutures are primarily used to oppose tissues together to assist and accelerate the recovery process after an incident or surgical operation)

A retrospective, multicenter, observational, real-world post-market clinical follow-up study to evaluate the safety and performance of MEGASORB™ surgical suture used for general soft tissue approximation and/or ligation, including use in ophthalmic surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/065476
Enrollment
260
Registered
2024-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Meril Life Sciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All consecutive patients who underwent surgical experience like general soft tissue approximation and/or ligation, including use in ophthalmic surgery using MEGASORB™ Surgical suture. - Patients who have completed a minimum of 03 month after the surgery using MEGASORB™ surgical suture

Exclusion criteria

Exclusion criteria: Since this is a retrospective review of data, there are no specific exclusion Criteria

Design outcomes

Primary

MeasureTime frame
1. Wound disruptions 2. Intraocular Pressure (IOP) following hypotonyrelated complications 3. Intra-operative complication 4. Surgical Site Infection 5. Time to wound closureTimepoint: 1. Time frame: Discharge, through 7 days, through 30 days 2. Time Frame: Pre-operative, postoperative, through 7 days, through 30 days 3. Time Frame: During Procedure 4. Time Frame: Discharge, through 7 days, through 30 days 5. Time Frame: Intra-operative—

Secondary

MeasureTime frame
1. Wound healing 2. Length of hospital stay 3. Re-intervention 4. Surgical Site Infection 5. Adverse events related to suture Timepoint: 1. Time Frame: Through 7 days, through 30 days, through 3 months 2. Time Frame: Hospital admission to discharge 3. Time Frame: Through 7 days, through 30 days, through 3 months 4. Time Frame: Discharge, through 7 days, through 30 days, through 3 months 5. Time Frame: Through 7 days, through 30 days, through 3 months 6.—

Countries

India

Contacts

Public ContactDr Kirankumar Shetty

Meril Life Sciences Pvt. Ltd

kirankumar.shetty@merillife.com9743700109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026