A retrospective, multicenter, observational, real-world post-market clinical follow-up study to evaluate the safety and performance of MEGASORBâ„¢ surgical suture used for general soft tissue approximation and/or ligation, including use in ophthalmic surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 260
- Locations
- 2
- Primary Endpoint
- 1. Wound disruptions
Study Overview
Brief Summary
MEGASORBSURGICAL SUTURE PMCF STUDY: A retrospective, multicenter, observational, real-world post-market clinical follow-up study to evaluate the safety and performance of MEGASORBâ„¢ surgical suture used for general soft tissue approximation and/or ligation, including use in ophthalmic surgery
Study Design: A retrospective, multicenter, observational, real-world postmarket clinical follow-up study
Patient Population: All consecutive patients who underwent surgical experience like general soft tissue approximation and/or ligation, including use in ophthalmic surgery using MEGASORBâ„¢ Surgical suture, and have completed a minimum of 3-month follow-up.
Objective: To evaluate the safety and performance of MEGASORBâ„¢ surgical suture used for general soft tissue approximation and/or ligation, including use in ophthalmic surgery cutting in realworld patients.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 4.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All consecutive patients who underwent surgical experience like general soft tissue approximation and/or ligation, including use in ophthalmic surgery using MEGASORBâ„¢ Surgical suture.
- •Patients who have completed a minimum of 03 month after the surgery using MEGASORBâ„¢ surgical suture.
Exclusion Criteria
- •Since this is a retrospective review of data, there are no specific exclusion Criteria.
Outcomes
Primary Outcomes
1. Wound disruptions
Time Frame: 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
2. Intraocular Pressure (IOP) following hypotonyrelated complications
Time Frame: 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
3. Intra-operative complication
Time Frame: 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
4. Surgical Site Infection
Time Frame: 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
5. Time to wound closure
Time Frame: 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 Outcomes
- 1. Wound healing(2. Length of hospital stay)
Investigators
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd