A prospective, single-arm, open-label, multi-centre, observational, post-market clinical follow-up study to investigate the triclosan-resistant pathogenic colonization on FILAPRON AB(TM) Absorbable Poly (glycolide-co-caprolactone) Surgical Suture U.S.P in a real-world setting.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- 1.Surgical site infection
研究概览
简要总结
Study Name: A prospective, single-arm, open-label, multi-centre, observational, post-market clinical follow-up study to investigate the triclosanresistant pathogenic colonization on FILAPRON AB™ Absorbable Poly (glycolide-co-caprolactone) Surgical Suture U.S.P in a realworld setting.
Short Title: FILAPRON AB ABSORBABLE SUTURE
Protocol ID, Version & Date: MES/FILAPRON AB ABSORBABLE SUTURE_Version 1.0.0_15-Feb-2025
Study Device: FILAPRON AB™ Absorbable Poly (glycolide-co-caprolactone) Surgical Suture U.S.P.
Indication: FILAPRON AB™ sutures are intended for use in general soft tissue approximation and /or ligation where an absorbable material is indicated but not for use in cardiovascular or neurological tissues or ophthalmic surgery.
Objective: This study aims to investigate the triclosan-resistant pathogenic colonization on FILAPRON AB™ Absorbable Poly (glycolide-cocaprolactone) Surgical Suture U.S.P in real-world settings.
Study Population: The study includes Subjects who require FILAPRON AB™ Absorbable Poly (glycolide-co-caprolactone) Surgical Sutures for approximation and /or ligation of general soft tissues except for cardiovascular, neurological tissues or ophthalmic surgery.
Study Design: A prospective, single-arm, open-label, multi-centre, observational, post-market clinical follow-up study.
Rationale of the Study: The selection of suture material is crucial for ensuring effective tissue approximation and optimal wound healing while minimizing complications such as scarring, ischemia, and tissue damage. Surgeons need to carefully choose a suture based on factors like the tissue type, required strength, and the duration of support needed. Absorbable sutures break down in the body over time due to hydrolysis or enzymatic activity. They are commonly used for internal tissues where removal is not possible. FILAPRON AB™ is a sterile, non-pyrogenic, synthetic absorbable monofilament suture composed of poly (glycolide-co-caprolactone) and coated with triclosan. FILAPRON AB™ sutures are intended for use in general soft tissue approximation and /or ligation where an absorbable material is indicated but not for use in cardiovascular or neurological tissues or ophthalmic surgery. Despite antibiotic treatment, there remains a potential risk of SSI due to pathogens resistant to triclosan. Therefore, the current study is to investigate the triclosan-resistant pathogenic colonization on FILAPRON AB™ absorbable poly (glycolideco-caprolactone) surgical suture U.S.P in a real-world setting after the fixation of soft tissue approximation.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects who will undergo general soft tissue approximation and /or ligation.
- •2.Subject who undergoing treatment of FILAPRON AB(TM) suture.
- •3.Subject is 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.
- •4.Subject is not able to write on behalf of the Subject, the Subject’s LAR (Legally acceptable representative) can fill out the informed consent.
- •5.Subject is willing and able to comply with postoperative scheduled clinical evaluations.
- •6.Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained.
排除标准
- •1.Subject who does not able to provide the written informed consent form.
- •2.Subject for whom absorbable sutures are not recommended or suitable should avoid their use in situations requiring prolonged tissue approximation under stress.
- •3.FILAPRON AB™ absorbable suture must not be used for abdominal or facial tissue closure.
- •4.Subjects with known sensitivity to suture material, i.e., glycolide, caprolactone, and triclosan.
- •5.Subjects who require surgeries of either ophthalmic, cardiovascular, or central nervous system.
- •6.Subject with an immune compromised medical condition.
- •Pregnant women.
结局指标
主要结局
1.Surgical site infection
时间窗: 1.Time Frame: 7 days, 15days, 30 days and 4 months | 2.Time Frame: Through Discharge, 7 days, 15 days, 30 days and 4 months | 3.Time Frame: Intra operative
2.Adverse events
时间窗: 1.Time Frame: 7 days, 15days, 30 days and 4 months | 2.Time Frame: Through Discharge, 7 days, 15 days, 30 days and 4 months | 3.Time Frame: Intra operative
3.Success rate
时间窗: 1.Time Frame: 7 days, 15days, 30 days and 4 months | 2.Time Frame: Through Discharge, 7 days, 15 days, 30 days and 4 months | 3.Time Frame: Intra operative
次要结局
- 1.Triclosan resistance of pathogens(2.Bacterial selection & microscopic characterization)
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd