A prospective, single-arm, multicenter, observational post-marketing surveillance study to investigate the triclosan-resistant pathogenic colonization on MITSU ABâ„¢ absorbable poly (glycolide/L-lactide) triclosan- coated surgical suture U.S.P after soft tissue approximation in a real-world setting
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- 1.Superficial Surgical site infection (SSI)
研究概览
简要总结
MITSU AB Absorbable Suture: A prospective, single-arm, multicenter, observational post-marketing surveillance study to investigate the triclosan-resistant pathogenic colonization on MITSU ABâ„¢ absorbable poly (glycolide/L-lactide) triclosan- coated surgical suture U.S.P after soft tissue approximation in a real-world setting
Protocol Number: MES/ MITSU AB Absorbable Suture
Protocol Version: Version 2.0.0 Issue date: 01-Oct-2024
Study Device: MITSU ABâ„¢ absorbable poly (glycolide/L-lactide) surgicalsuture U.S.P with antibacterial triclosan coating
Indication: MITSU ABâ„¢ absorbable suture is indicated for use in general soft tissue approximation and/or ligation except for ophthalmic, cardiovascular, and neurological tissues.
Objective: The study aims to investigate the triclosan-resistant pathogenic colonization on MITSU ABâ„¢ absorbable poly (glycolide/L-lactide) surgical suture U.S.P in a realworld setting.
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. MITSU ABâ„¢ is a copolymer (90% glycolide and 10% L-lactide) suture layered with triclosan, an antibacterial agent. Despite the presence of an antibiotic, there is a putative possibility of SSI due to triclosan-resistant pathogens. Hence, the present study is to investigate the triclosan-resistant pathogenic colonization on MITSU ABâ„¢ absorbable poly (glycolide/L-lactide) surgical suture U.S.P in a real-world setting after the fixation of soft tissue approximation wherein use of absorbable suture is appropriate.
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
- •All consecutive patients who will undergo general soft tissue approximation and or ligation except for ophthalmic, cardiovascular, and neurological tissues.
- •The Subject must be treated with MITSU AB.
- •The 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.
- •If the Subject is not able to write on behalf of the Subject, the Subjects LAR can fill out the informed consent.
- •The Subject is willing and able to comply with postoperative scheduled clinical evaluations.
- •Subjects who are able to give voluntary written informed consent to participate in this clinical investigation and from whom consent has been obtained
- •Women who have undergone a Cesarean section and received sutures.
排除标准
- •The Subject who does not approve the informed consent is not eligible for the study.
- •MITSU AB absorbable suture is not recommended where an extended approximation of tissues under stress is required.
- •MITSU AB absorbable suture should not be used in patients having any known sensitivity to suture material, i.e., glycolide, L-lactide, calcium stearate, and triclosan.
- •Subjects who require surgeries of either ophthalmic, cardiovascular, or central nervous system are not considered for MITSU AB absorbable suture.
- •Any Subject with an immune compromised medical condition shall not be considered.
- •The pregnant women shall be excluded.
结局指标
主要结局
1.Superficial Surgical site infection (SSI)
时间窗: 1.Time Frame: Discharge, 7 days, 15 days, 30 postoperatively | 2.Time Frame: Discharge, 7 days, 15 days , 30 days post operation | 3.Time frame: Discharge, 7days, 15 days, 30 days post operation | 4.Time Frame: 7 days, 15 days, 30days
2.Triclosan resistance of pathogens
时间窗: 1.Time Frame: Discharge, 7 days, 15 days, 30 postoperatively | 2.Time Frame: Discharge, 7 days, 15 days , 30 days post operation | 3.Time frame: Discharge, 7days, 15 days, 30 days post operation | 4.Time Frame: 7 days, 15 days, 30days
3.Bacterial selection and microscopic characterization
时间窗: 1.Time Frame: Discharge, 7 days, 15 days, 30 postoperatively | 2.Time Frame: Discharge, 7 days, 15 days , 30 days post operation | 3.Time frame: Discharge, 7days, 15 days, 30 days post operation | 4.Time Frame: 7 days, 15 days, 30days
4.Wound Healing Grade
时间窗: 1.Time Frame: Discharge, 7 days, 15 days, 30 postoperatively | 2.Time Frame: Discharge, 7 days, 15 days , 30 days post operation | 3.Time frame: Discharge, 7days, 15 days, 30 days post operation | 4.Time Frame: 7 days, 15 days, 30days
次要结局
- 1.Postoperative incisional pain score (Visual Analogue Scale or VAS)(2.Re-admission due to SSI-related complications)
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd