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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- 1. Wound disruptions
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 4.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •Since this is a retrospective review of data, there are no specific exclusion Criteria.
结局指标
主要结局
1. Wound disruptions
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 1. Wound healing(2. Length of hospital stay)
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd