FILAXYN AB ABSORBABLE SUTURE: A prospective, observational, single-arm, open-label, multi-center, post-market clinical follow-up study to investigate the triclosan-resistant pathogenic colonization on the FILAXYN AB Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- 1.Superficial Surgical site infection
研究概览
简要总结
Study Name A prospective, observational, single-arm, open-label, multi-center, post-market clinical follow-up study to investigate the triclosanresistant pathogenic colonization on the FILAXYN AB Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P.
Short Title FILAXYN AB ABSORBABLE SUTURE
Protocol ID, Version and Date MES/FILAXYN AB ABSORBABLE SUTURE_Version 1.0.0_15- Feb-2025
Study Device FILAXYN AB™ ABSORBABLE POLY(P-DIOXANONE) SURGICAL SUTURE U.S.P
Rationale of the Study An absorbable suture is a promising option when compared to non-absorbable sutures in terms of reduced clinical time due to minimal postoperative visits and surgery site aesthetics. Absorbable sutures are of fundamental importance in surgical outcomes. FILAXYN AB™ Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P is a sterile synthetic absorbable monofilament suture
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects who are willing to be treated with the FILAXYN AB™ Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P for use in general soft tissue approximation, including use in pediatric cardiovascular tissue and ophthalmic surgery (Other than contact with cornea and sclera).
- •Subjects enroll both men and women and all general population adults of all age groups for soft tissue approximation and/or ligation.
- •Pediatric subjects with cardiovascular and ophthalmic surgery (other than contact with cornea and sclera).
- •Subjects must be willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form.
- •In the case of a Subject and LAR being illiterate, a literate impartial witness is required during consenting.
- •5.The subject is not able to write on behalf of the Subject, the Subject’s LAR (Legally acceptable representative) can fill out the informed consent.
- •Subject is willing and able to comply with scheduled postoperative clinical evaluations.
排除标准
- •Subjects who are not treated with the FILAXYN AB™ Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P.
- •Adult Subjects who require cardiovascular, microsurgery, and neurological tissue surgeries, FILAXYN AB™ Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P.
- •FILAXYN AB™ Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P cannot be used in direct contact with the heart,the central circulatory system, or the central nervous system.
- •Subjects who have known allergic reactions to Triclosan.
- •Pregnant women.
结局指标
主要结局
1.Superficial Surgical site infection
时间窗: 1.Time Frame: | Through discharge, 7 days, 15 days, 1 month, 3 months | 2.Time Frame: Through | discharge, 7 days, 15 days, 1 month, 3 months | 3.Through discharge, 7 | days, 15 days, 1 month, 3 | months
2.Surgical Suture success
时间窗: 1.Time Frame: | Through discharge, 7 days, 15 days, 1 month, 3 months | 2.Time Frame: Through | discharge, 7 days, 15 days, 1 month, 3 months | 3.Through discharge, 7 | days, 15 days, 1 month, 3 | months
3.Adverse Events or Adverse Reactions or Complications
时间窗: 1.Time Frame: | Through discharge, 7 days, 15 days, 1 month, 3 months | 2.Time Frame: Through | discharge, 7 days, 15 days, 1 month, 3 months | 3.Through discharge, 7 | days, 15 days, 1 month, 3 | months
related to Suture
时间窗: 1.Time Frame: | Through discharge, 7 days, 15 days, 1 month, 3 months | 2.Time Frame: Through | discharge, 7 days, 15 days, 1 month, 3 months | 3.Through discharge, 7 | days, 15 days, 1 month, 3 | months
次要结局
- 1.Triclosan resistance to pathogens(2.Bacterial selection & microscopic characterization)
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd