Abdomen Closure Using Triclosan Coated Absorbable Suture vs Uncoated Sutures of the Same Base Material
试验速览
- 阶段
- 2 期
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- quality and quantity of wound discharge
研究概览
简要总结
After open colo-rectal surgery the surgical site infection (SSI) is very high among abdominal surgeries. The goal of the investigators randomized, prospective, multicentric, internet-based study is to compare rate of SSI after surgery of colon and rectum by using triclosan-coated suture for abdominal wall closure. 180-180 cases in seven centres are involved in this study. Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus). Triclosan is an antiseptic material which the investigators hope will provide better local infection control at the site with reducing the risk of bacterial colonisation.
详细描述
After open colo-rectal surgery the surgical site infection (SSI) is very high among abdominal surgeries. The goal of our randomized, prospective, multicentric, internet-based study is to compare rate of SSI after surgery of colon and rectum by using triclosan-coated suture for abdominal wall closure. Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus). Triclosan is an antiseptic materia which we hope provides better local infection control at the site with reducing the risk of bacterial colonisation.
attached website: www.itplan.hu/sebstudy/ Randomizing patients: 1. logging in (completing the ID pannel) 2. on-line randomization 3. patient appears on list 4. operation (recording details) 5. recording - post-operation events
- complications
- control examination
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective (subjected to bowel preparation) operations
- •Benign or malignsnt colon or rectal disease
- •Age: 18-80
- •Bowel opening is made during operation
排除标准
- •Cannot be randomized:
- •Systemic diseases influencing local surgical site healing Insulin-dependent diabetes mellitus Child B-C liver cirrhosis Kidney disease requiring dialysis Immune-suppression treatment IBD Acute surgery or unpreparated bowel After being informed patient does not sign the statement of consent
- •To be excluded later:
- •Surgically incurable tumour Septic state or complication occurred in the post-operational stage Patient withdraws the signed consent before the examination is closed
- •Undesirable complication:
- •Sterile surgical site separation Suture break during the post-operational stage
结局指标
主要结局
quality and quantity of wound discharge
时间窗: 30 days
次要结局
- number of applied different types of bandages(30 days)
- charges of wound care(30 days)