Assessment of Optilene® Suture Material for Skin Closure (Dermal Sutures). A Prospective 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
- 172
- 试验地点
- 1
- 主要终点
- Surgical Site Infection Rate
研究概览
简要总结
In this non-interventional study, Optilene® suture will be evaluated for skin closure in adult patients.
详细描述
The study is designed as a prospective, unicentric and single-arm observational study to evaluate Optilene® suture material for skin closure.
The product under investigation will be used in routine clinical practice and according to the Instructions for Use (IFU). After operation the investigator will examine the patients at discharge, at 10±5 days after surgery (removal of the suture) and 30±10 days postoperatively.
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
- •Adult patients undergoing skin closure using Optilene® suture material.
- •Small (0.5 cm - 10 cm) linear minimally contaminated incision/laceration in the trunk, neck or extremities (in the event that more than one incision is performed in the same patient, only one incision will be included).
- •Written informed consent.
排除标准
- •Emergency surgery.
- •Transplant surgery.
- •Pregnancy.
- •Facial laceration or incision.
- •Visible dirt in the wound.
- •Non-linear shape.
- •Patient with limb ischemia.
- •Patient taking medication that might affect wound healing (i.e. cytotoxic antineoplastic and immunosuppressive agents, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), anticoagulants).
- •Patient 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 approximately 10±5 days postoperatively.
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. Other surgical site infections are more serious and can involve tissues under the skin, organs, or implanted material.
次要结局
- Surgical Site Infection Rate(at follow-up examination approximately 30±10 days postoperatively)
- Development of Cosmetic Outcome(at discharge (up to 5 days postoperatively), at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively)
- Development of Pain: Visual Analogue Scale (VAS)(at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively)
- Wound dehiscence rate(at follow-up examination approximately 30±10 days postoperatively)
- Duration of surgery(intraoperatively)
- Cumulative rate of Adverse Events during the study period(at discharge (up to 5 days postoperatively), at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively)
- Development of Satisfaction of the patient: Visual Analogue Scale (VAS)(at suture removal (approximately 10±5 days postoperatively) and at follow-up visit approximately 30±10 days postoperatively)
- Handling of the suture material(intraoperatively)