Assessment of DAFILON® Suture Material for Skin Closure: A Prospective, Multicentric, International, 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
- 115
- 试验地点
- 2
- 主要终点
- Combination of Surgical Site Infection (SSI) and Wound Dehiscence
研究概览
简要总结
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon®) will be evaluated for skin closure in adult and pediatric patients. The aim of the study is to collect clinical data on the performance of Dafilon® for skin closure. The results of this study will generate further clinical evidence for the use and the benefit of a non-absorbable surgical suture material produced from polyamide. Furthermore, the proactive collection of clinical data for Dafilon® suture will support the maintenance of the suture material on the market, so that in the future other patients can receive the suture material for skin closure.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Combination of Surgical Site Infection (SSI) and Wound Dehiscence
时间窗: until suture removal 10±5 days postoperatively.
The hypotheses of the current study is that the combined endpoint which consists of the sum of the wound dehiscence and SSI rate will not be inferior to the rate of 13% published by Sajid M. S. et al., 2014 \[Systematic review of absorbable vs non-absorbable sutures used for the closure of surgical incisions. World J Gastrointest Surg 2014 27;6(12): 241-247\]
次要结局
- Progress of Pain: Visual Analogue Scale (VAS)(until day of discharge (approximately 1-2 days postoperatively) and 10±5 days postoperatively)
- Length of hospital stay(until day of discharge (approximately 1-2 days postoperatively))
- Individual dehiscence rate at postoperative Examination(10±5 days postoperatively)
- Progress of Wound healing(until day of discharge (approximately 1-2 days postoperatively), 10±5 days post operatively and at follow-up visit)
- Progress of Satisfaction: Visual Analogue Scale (VAS)(until day of discharge (approximately 1-2 days postoperatively) and 10±5 days postoperatively)
- Adverse events(until 10±5 days postoperatively)
- Progress of Cosmetic result(at 10±5 days (suture removal) and at optional follow-up visit)
- Rate of hypertrophic scar(10±5 days postoperatively (suture removal))
- Rate of keloid scar(10±5 days postoperatively (suture removal))
- Assessment of the handling of the suture material(intra-operatively)
- Individual rate of surgical site infection (SSI) at discharge(until day of discharge (approximately 1-2 days postoperatively))
- Individual rate of surgical site infection (SSI) at postoperative Examination(10±5 days postoperatively)
- Individual dehiscence rate at discharge(until day of discharge (approximately 1-2 days postoperatively))