Single Center Open-Label Post Market Clinical Follow-Up (PMCF) -Study on the Performance of Safety of SILKAM® Suture Material in Oral Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Surgical Wound Dehiscence rate
研究概览
简要总结
Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational study.
详细描述
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 is intended to be used for oral surgery. All patients enrolled will be prospectively followed until suture removal, which takes place approximately one week post-operatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing mucosal wound closure using SILKAM® as suture material in oral surgery (in the event that more than one incision is performed in the same patient, only one incision will be considered).
排除标准
- •Patients taking medication that might affect wound healing
- •Patients having a condition that might affect wound healing.
- •Patients with hypersensitivity or allergy to the suture material.
- •Participation in another (Randomized) Clinical Trial / Clinical Study.
- •Non-compliance of patient (i.e. dementia).
结局指标
主要结局
Surgical Wound Dehiscence rate
时间窗: until day of suture removal (approximately 1 week after surgery)
Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.
Complication rate
时间窗: until day of suture removal (approximately 1 week after surgery)
Complications rate according to the "Classification of Askar" as Grade 1 (Localized complication(s) accompanied by no adverse effects on the success of the surgery) and Grade 2 (Localized complication(s) accompanied by adverse effects on the success of the surgery).
次要结局
- Satisfaction of the patient using the visual analogue scale (VAS 1-100)(until day of suture removal (approximately 1 week after surgery))
- Complication rate(until day of suture removal (approximately 1 week after surgery))
- Pain assessment using the visual analogue scale (VAS 1-100)(until day of suture removal (approximately 1 week after surgery))
- Wound healing assessment using the visual analogue scale (VAS 1-100)(until day of suture removal (approximately 1 week after surgery))
- Assessment of the handling of the suture material(intraoperatively)