A Prospective, Multicenter, Observational, Single-Arm, Open-Label, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Performance of PINION PDO Knotless Suture in Real-World Clinical Practice
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 189
- 试验地点
- 6
- 主要终点
- 1. Surgical site infection
研究概览
简要总结
Title :A prospective, single-arm, multi-centre, observational, post marketing surveillance study to evaluate the safety and performance of PINION™ PDO Knotless Suture in real-world settings
Short Title PINION PDO PMS
Protocol ID, Version and Date MES/ PINION PDO PMS Version 1.0.0 dated 21-Dec-2024
Study device PINION PDO Absorbable Poly Knotless Suture
Indication PINION PDO Knotless Suture is indicated for use in soft tissue approximation where absorbable sutures use is appropriate.
Objective This study aims to evaluate the safety and performance of PINION PDO Knotless sutures in real-world settings.
To evaluate the suture’s ability to significantly reduce surgical time.
Minimize blood loss during procedures
Decrease overall surgical difficulty.
Uniform tension across the wound.
Study Design A prospective, single-arm, multi-centre, observational, postmarketing surveillance study
Rationale of the Study Knotless sutures are of fundamental importance in surgical outcomes. PINION™ PDO Knotless Suture contains bidirectional oriented barbs to anchor tissues and does not require knots to approximate opposing edges of a wound. Tying knots on the barbed section of the material will damage the barbs and potentially reduce the suture tensile strength and barb effectiveness. Hence, the present study is to evaluate the safety and performance of a sterile, synthetic, absorbable monofilament suture comprised of Poly in the fixation of soft tissue
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 5.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •The Subject must be treated with PINION™ PDO suture with a soft suture approximation procedure.
- •The Subject must be willing and able to provide written Informed Consent by signing and dating the Institutional Review Board (IRB) or Ethics Committee approved Informed Consent form
- •In the case of a Subject and LAR being illiterate, a literate impartial witness is required during consenting.
- •If the Subject is not able to write on behalf of the Subject, the Subjects LAR Legally acceptable representative can fill out the informed consent.
- •Subject must be willing to undergo soft tissue repair and be able to undergo all other study procedures as outlined in this protocol.
- •The subject is willing and able to comply with postoperative scheduled clinical evaluations.
排除标准
- •Participants are not suitable for anesthesia or endovascular surgery, such as those with severe respiratory, heart, lung, liver, kidney disease or coagulation disorders such as hemophilia.
- •Participants undergoing neural tissue procedures and tendinous tissue repair or surgery.
- •Participants scheduled for ophthalmic surgery and microsurgery.
- •Participants undergoing urinary tract and biliary tract surgery where prolonged contact with salt solutions is anticipated.
- •Participants with a history of HIV or any other systemic infections.
- •Participants with ongoing sepsis or septicemia, ongoing bacterial infection or on antibiotic treatment other than prophylaxis antibiotics given prior to and post-surgery.
- •Participants with a history of prior surgery within the past one month with Surgical Site Infection.
- •Pregnant or breast-feeding women.
- •Participants who are unwilling or unable to sign the Informed Consent Document.
结局指标
主要结局
1. Surgical site infection
时间窗: 1. Time Frame: Intra-operative | 2.Time Frame: Intra-operative | 3.Time Frame: 7 days ± 2 days, 30 days ±7 days
2.wound complications
时间窗: 1. Time Frame: Intra-operative | 2.Time Frame: Intra-operative | 3.Time Frame: 7 days ± 2 days, 30 days ±7 days
3.Adverse event
时间窗: 1. Time Frame: Intra-operative | 2.Time Frame: Intra-operative | 3.Time Frame: 7 days ± 2 days, 30 days ±7 days
4.Intraoperative complications
时间窗: 1. Time Frame: Intra-operative | 2.Time Frame: Intra-operative | 3.Time Frame: 7 days ± 2 days, 30 days ±7 days
次要结局
- 1.Length of hospital stay(2.Re-admission rate)
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd