Abdomen Closure Using Triclosan Coated Absorbable Suture vs Uncoated Sutures of the Same Base Material
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- quality and quantity of wound discharge
研究概览
简要总结
After open colorectal 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 separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS versus 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 colorectal 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 separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS versus PDS-Plus). Triclosan is an antiseptic material 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 panel) 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 malignant 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
- •Acute surgery or unprepared 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
研究组 & 干预措施
triclosan
Two arms are separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).
干预措施: abdominal wall closure (Procedure)
uncoated
Two arms are separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).
干预措施: surgical site infection (Procedure)
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)