Prospective Descriptive Multicentre Pilot Study On The Effectiveness and Safety Of Optilene® Silver Mesh Elastic In Prevention Of Surgical Site Infection (SSI) And Incisional Hernia (IH)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Aesculap AG
- 入组人数
- 110
- 试验地点
- 9
- 主要终点
- Surgical Site Infection (SSI) A2/A3 rate
研究概览
简要总结
The aim of the study is to describe the effectiveness of Optilene® Silver Mesh Elastic on prevention of surgical site infection (SSI) at 6 months follow-up in patients undergoing urgent laparotomy by collecting clinical data on the SSI rates, IH rates and overall clinical performance of Optilene® Silver Mesh Elastic used for the prevention of incisional hernia as prophylactic mesh in patients that require urgent median laparotomy in clinical routine.
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 (18 years or older)
- •Surgical procedure requiring urgent, primary median laparotomy, which are classified as "Class III/Contaminated" or "Class IV/Dirty-Infected" regarding the CDC classification.
- •These include but are not limited to:
- •Vascular surgery
- •Colon and rectum
- •Hepatobiliary
- •Gastrointestinal
- •Gynecology
- •Abdominal Aortic Aneurysm (AAA) repair
- •Right hemicolectomy
- •Left hemicolectomy
- •Sigmoidectomy
- •Anterior resection
- •Abdominoperineal amputation
- •Exploratory laparotomy
- •Cholecystectomy
- •Cholecystectomy and choledocotomy
- •Written informed consent
排除标准
- •Pregnancy
- •Breast feeding
- •Patients < 18 years old or patients who are still in the growth phase
- •Contaminated and infected areas
- •Hypersensitivity to silver
- •Direct contact with the viscera
- •Previous allergic reactions to components of the device
- •Patient with previous laparotomy
- •Transverse laparotomy
- •Patients with previous hernia repair
- •Simultaneous participation in another investigational clinical trial (drug or medical studies)
- •Patients with active oncologic treatment (chemo and radiotherapy)
- •Underlying autoimmune disease
- •Recent cardiovascular complication
- •Gynecology surgery
- •Urology surgery
- •Vascular surgery
结局指标
主要结局
Surgical Site Infection (SSI) A2/A3 rate
时间窗: at 6 months follow-up
SSIs remain a significant clinical problem as they are associated with substantial mortality and morbidity and impose severe demands on healthcare resources. Centers for Disease Control and Prevention Surgical Site Infection (SSI) Classification System differentiates Superficial SSI (A1), Deep Incisional SSI (A2) and Infection with involvement of organs/body cavities (A3). Only cases of A2 and A3 are considered for the Primary Outcome and are compared to rates from reference literature
次要结局
- Cumulative Surgical Site Infection (SSI) A2/A3 rate during the study period(at 1 month, 1 year and 2 year follow-up.)
- Handling of the Optilene® Silver Mesh Elastic(intraoperatively)
- Length of hospital stay(at discharge (approximately up to 10 days after surgery))
- Time to return to work(at all postoperative examinations with a single value for each individual patient)
- Incisional hernia (IH) rate during the study period(repeatedly at 6 months, 1 year and 2 year follow-up.)
- Cumulative rate of of postoperative complications during the study period(at discharge (up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up)
- Development of Pain: Visual Analogue Scale (VAS)(at discharge (approximately up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up, using the VAS score)