A Randomized Controlled Clinical Trial Evaluating the Efficacy of Silverlon® in Preventing Surgical Site Infection Following Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Surgical Site Infection
研究概览
简要总结
This clinical study is a prospective, randomized, controlled trial of patients undergoing elective colorectal surgical procedures that receive an abdominal skin incision of at least 6 cm. Treatment with Silverlon® will be compared to standard postoperative dressings of 4x4 Gauze and paper tape. Patients will be randomized with a 1:1 treatment allocation ratio to receive either 1) Silverlon® or 2) standard postsurgical dressing. Neither the Investigators nor the participants will be blinded to the treatment modality after randomization.
Silver has long been known to have antimicrobial properties. It interacts with structural proteins and DNA, inhibiting bacterial replication and causing fatal structural changes within the cell wall. It has broad antimicrobial activities and unlike antibiotics, it is rarely associated with microbial resistance. Silverlon® is a silver-nylon dressing specifically designed for surgical wounds to prevent the development of surgical site infections. It is an easy to use product with no known microbial resistance or adverse effects. The efficacy of Silverlon® in preventing surgical site infections has been shown in several retrospective studies but as of yet has not been tested in a prospective fashion. The objective of this study is to perform a prospective, randomized, clinical trial directly comparing the incidence of surgical site infections in patients treated with Silverlon® to standard postoperative dressing following elective colorectal surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •All patients undergoing elective colorectal surgery by a trained colorectal surgeon with an abdominal skin incision of at least 3 cm
- •Patients that are willing and able to comply with the requirements of the protocol including follow-up requirements
- •Patients willing and able to sign a study specific informed consent
排除标准
- •Patients that fail to meet the skin incision size criteria
- •Patients with a known allergy to silver
- •Patients less than 18 years of age
- •Any contraindication to undergoing a surgical procedure under general anesthesia
- •Patients with preoperative evidence of a current abdominal wall infection/surgical site infection from a previous laparotomy/laparoscopy
- •Patients that have received antibiotic therapy within the week prior to surgery
- •Patients with preoperative evaluation suggestive of an intra-abdominal process that would preclude full closure of the skin
- •Patients with a previously placed anterior abdominal wall mesh that is not planned to be completely removed during the planned procedure
- •Women who are pregnant or breast feeding or are considering becoming pregnant during the follow-up period
- •Mental incompetence as determined by the Investigator which would affect participation in the study
- •Concurrently participating in any other investigational study
结局指标
主要结局
Surgical Site Infection
时间窗: Day of surgery up to 30 days post operatively
We will monitor the incision from the day of surgery to post operative day 30 to determine if the incision needs antibiotics.
次要结局
未报告次要终点
研究者
Jorge Marcet
Professor, Department of Surgery
University of South Florida