SUTURE PMCF STUDY(Sutures are primarilyused to oppose tissues together to assist and accelerate the recovery process after an incidentor surgical operation)
Not Applicable
Not yet recruiting
- Conditions
- Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
- Registration Number
- CTRI/2024/04/065476
- Lead Sponsor
- Meril Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Since this is a retrospective review of data, there are no
specific exclusion Criteria
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Wound disruptions <br/ ><br>2. Intraocular Pressure (IOP) following hypotonyrelated complications <br/ ><br>3. Intra-operative complication <br/ ><br>4. Surgical Site Infection <br/ ><br>5. Time to wound closureTimepoint: 1. Time frame: Discharge, through 7 days, through 30 days <br/ ><br>2. Time Frame: Pre-operative, <br/ ><br>postoperative, through 7 days, through 30 days <br/ ><br>3. Time Frame: During <br/ ><br>Procedure <br/ ><br>4. Time Frame: Discharge, <br/ ><br>through 7 days, through 30 days <br/ ><br>5. Time Frame: Intra-operative
- Secondary Outcome Measures
Name Time Method 1. Wound healing <br/ ><br>2. Length of hospital stay <br/ ><br>3. Re-intervention <br/ ><br>4. Surgical Site Infection <br/ ><br>5. Adverse events related to suture <br/ ><br>Timepoint: 1. Time Frame: Through 7 days, <br/ ><br>through 30 days, through 3 months <br/ ><br>2. Time Frame: Hospital <br/ ><br>admission to discharge <br/ ><br>3. Time Frame: Through 7 days, <br/ ><br>through 30 days, through 3 months <br/ ><br>4. Time Frame: Discharge, <br/ ><br>through 7 days, through 30 days, through 3 months <br/ ><br>5. Time Frame: <br/ ><br>Through 7 days, through 30 days, through 3 months <br/ ><br>6.