Assessment of Performance of Silkam® Suture Material for Skin Closure - a Prospective, Single Center, Single Arm, Observational Study in Daily Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Surgical Site Infection Rate
研究概览
简要总结
Assessment of performance of Silkam® suture material for skin closure. A prospective, single center, single arm, observational study in daily practice.
详细描述
The prospective, monocentric, single-arm, observational Post Market Clinical Follow-Up (PMCF) study is done to continue to evaluate the safety and performance of Silkam® suture material for skin closure under clinical routine. Safety and effectiveness parameters commonly used in skin closure are to be used to evaluate the performance of the suture material.
The aim of this Non Interventional Study is to collect systematically and proactively different clinical parameters regarding safety, effectiveness and performance of Silkam® suture material under the daily routine clinical practice when used for skin closure as intended.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult and paediatric patients undergoing skin closure using Silkam® as suture material.
- •Written informed consent regarding the data collection for the PMCF study.
排除标准
- •Pregnancy
- •Visible dirty wounds
- •Patients taking medication that might affect wound healing
- •Patients with hypersensitivity or allergy to the suture material
结局指标
主要结局
Surgical Site Infection Rate
时间窗: at suture removal approx. 10 ± 5 days postoperative
A surgical site infection is an infection that occurs after surgery in the part of the body where the surgery took place. Surgical site infections can sometimes be superficial infections involving the skin only (A1). Other surgical site infections are more serious and can involve tissues under the skin, organs, or implanted material. (A2)
次要结局
- Pain: Visual Analogue Scale (VAS)(at suture removal approx. 10 ± 5 days postoperative)
- Cosmetic Outcome(at suture removal approx. 10 ± 5 days postoperative)
- Assessment of the handling of the suture material(intraoperative)
- Adverse Event Rate(at suture removal approx. 10 ± 5 days postoperative)
- Individual A1 Surgical Site Infection Rate(at suture removal approx. 10 ± 5 days postoperative)
- Individual A2 Surgical Site Infection Rate(at suture removal approx. 10 ± 5 days postoperative)
- Satisfaction of the patient: Visual Analogue Scale (VAS)(at suture removal approx. 10 ± 5 days postoperative)