Post-Marketing Clinical Follow-up (PMCF) Study for Skin Closure to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material. A Multicenter, International, Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Wound infection
研究概览
简要总结
The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for skin closure. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric and adult patients undergoing skin closure
- •Small linear minimally contaminated incision / lacerations on the trunk or extremities
- •Written informed consent
排除标准
- •Emergency surgery
- •Facial lacerations or incisions
- •Visible dirt in the wounds
- •Nonlinear shape
- •Patients taking medical consumption that might affect wound healing
结局指标
主要结局
Wound infection
时间窗: 3 months
Wound infection (Surgical site infection, SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC).
Incidence of wound dehiscence
时间窗: 3 months postoperatively
A dehiscence of the skin which needs surgical treatment with re-closure
Incidence of Tissue reaction / Inflammation
时间窗: 3 months postoperatively
Incidence of Suture removal
时间窗: 3 months postoperatively
Suture removal due to insufficient absorption
Incidence of Re-suturing
时间窗: 3 months post-operatively
Re-Suturing due to dehiscence
Cosmetic result
时间窗: 3 months post-operatively
Cosmetic result after surgery using the Patient and Observer Scar Assessment Scale (POSAS). Cosmetic result and the scar will be evaluated by the patient and the physician. Patient will rate the cosmetic outcome using the patient component of the Patient and Observer Scar Assessment Scale (POSAS). The physician will use the Observer component of the POSAS to assess the cosmetic outcome. Documentation of the scar will be performed 3 months postoperatively using photographs. Overall patient and observer satisfaction with the scar after 3 months postoperatively (POSAS).
Assessment of the handling of the suture material
时间窗: intraoperatively
Assessment of the handling of the suture material intra-operatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, tissue drag etc.) with 5 evaluations levels (excellent, very good, good, satisfied, poor).
次要结局
未报告次要终点