Does Antiseptic Coated Suture Reduce Pancreatic Fistula Rate After Pancreatoduodenectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 436
- 试验地点
- 1
- 主要终点
- Comparison of the rate of postoperative pancreatic fistula
研究概览
简要总结
The purpose of this study is to determine if the use of antiseptic-coated sutures is better than the use of the standard sutures in preventing postoperative fistulas within 90 days after pancreatoduodenectomy.
详细描述
This study is a randomized-controlled trial comparing the rate of post-operative pancreatic fistula (POPF) in patients undergoing pancreatoduodenectomy. This is a superiority study designed to determine whether the use of antiseptic-coated sutures (intervention arm) is superior to standard sutures (control arm) in regard to clinically significant POPF within 90 days following pancreatoduodenectomy. Patients will be randomized to receive either a pancreatoduodenectomy surgery utilizing antiseptic coated sutures or with non-coated standard sutures. The study hypothesize that the use of antiseptic-coated sutures will be associated with a reduction in the rate of POPF. Both sutures are currently available at our center and utilized in the procedure of interest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Subjects must be undergoing a scheduled pancreatoduodenectomy.
- •Age ≥18 years.
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients < 18 years old
- •Patients who are pregnant
- •Patients with history of previous pancreatic surgery
- •Patients who are unable to provide informed consent
研究组 & 干预措施
Standard (non-antiseptic coated) suture will be used.
You will undergo your primary surgery per standard practice at the discretion of your surgeon. Standard Sutures will be used during your operation.
干预措施: Standard (non-antiseptic coated) suture will be used. (Device)
Triclosan/antiseptic -coated suture
You will undergo your primary surgery per standard practice at the discretion of your surgeon. Triclosan/antiseptic -coated suture will be used. Ethicon PDSTM Plus Antibacterial Suture will be used at the layer of the pancreatojejunostomy and for the duration of the case.
干预措施: Triclosan/antiseptic -coated suture (Device)
结局指标
主要结局
Comparison of the rate of postoperative pancreatic fistula
时间窗: up to 90-day post operative
Comparison of the rate of postoperative pancreatic fistula-Grade C
Comparison of the rate of postoperative pancreatic fistula
时间窗: up to 90 days post-operative
comparison of the rate of postoperative pancreatic fistula- Biochemical leak
次要结局
- Improvement in Rate of clinically significant POPF(up to 90-days post-operative)
- Improvement in SSI rates between groups using CDC classification(up to 90-days post-operative)
- Surgical Site Occurrence requiring Procedural Intervention(up to 90 days post-operative)
- Hospital Length of Stay(up to 90-day post operative)
- Length of ICU stay(up to 90-day post operative)
- Surgical Site Infection(up to 90-day post operative)
- Surgical site occurrence(Up to 90 days post-operative)
- Post operative pancreatic fistula interventions(Up to 90 days post-operative)
研究者
Toms Augustin
Medical Director (Main Campus) - Safety, Quality and Patient Experience
The Cleveland Clinic