A Prospective Randomized Controlled Trial Comparing Duramesh™ With Polydioxanone Suture for Laparotomy Closure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- The primary outcome is SSE that occurs within 1 month after surgery.
研究概览
简要总结
This study is intended to demonstrate the non-inferiority of a Duramesh closure as compared to a polydioxanone closure for early surgical site events (SSE) (< 1 month), and Duramesh superiority to polydioxanone for the development of incisional hernia by 1 year for a laparotomy closure.
详细描述
This clinical investigation is designed to compare laparotomy closure with Duramesh to closure using PDS. The primary outcome is SSE that occurs within 1 month after surgery. Secondary outcomes that will be studied include device performance and technical success of the index-procedure, hernia occurrence/recurrence noted at 12 months after surgery, SSE and re-interventions that occur within 12 months of surgery, pain, implant palpability/sensation, surgeon and patient satisfaction, and quality of life.
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
- •Age 18 or greater
- •Abdominal laparotomy 5 cm in length or greater, either midline or non-midline
- •Isolated ostomy site takedown with or without parastomal hernia
- •Patient accepts participation and gives informed consent
- •Patient and investigator signed and dated the informed consent form prior to the index-procedure
排除标准
- •Pregnancy
- •Presence of clinically recognized hernia at laparotomy site (parastomal hernia noted at time of ostomy site takedown is not an exclusion criterion. Subclinical incidental small hernia < 1 cm in greatest dimension found at the time of a laparotomy is not an automatic exclusion criterion)
- •Prior hernia repair at laparotomy site
- •Use of planar mesh in addition to sutures for closure
- •CDC IV dirty or infected wound that causes the surgeon to leave the abdominal wall or skin incision open
- •Life expectancy less than 1 year
- •Patient is unable / unwilling to provide informed consent
- •Patient is unable to comply with the protocol or proposed follow-up visits
- •Patient is enrolled in another abdominal wall study
研究组 & 干预措施
Standard suture
2-0, 0, or Number 1 polydioxanone suture (PDS) is used as comparator.
干预措施: Polydioxanone suture (Device)
Duramesh
Laparotomy closure is associated with the occurrence of Surgical Site Events (SSEs) such as wound dehiscence and incisional hernias. Abdominal wall closure can also cause pain and discomfort, or can lead to intestinal obstruction.
Standard sutures can cut through otherwise intact tissue due to the presence of a sharp leading edge leading to repair failure. Meshes distribute forces and allow for tissue ingrowth. Duramesh combines the desirable principles of a mesh repair with the placement precision of a suture. It is the world's first device that both approximates tissue and allows ingrowth for a strong early repair.
Consequently, the expected clinical benefit is the reduced occurrence of Surgical Site Events such as incisional hernias. Additional benefits may include reduced pain and improved quality of life due to durable closure of the abdominal wall with Duramesh. This will be evaluated in this randomized study.
Size 1 Duramesh is used in this RCT. Duramesh is CE-marked.
干预措施: Duramesh (Device)
结局指标
主要结局
The primary outcome is SSE that occurs within 1 month after surgery.
时间窗: 1 month
This study is intended to demonstrate the non-inferiority of a Duramesh closure as compared to a polydioxanone closure for early surgical site events (SSE) (\< 1 month). SSE include: Seroma, Hematoma, Soft tissue breakdown, Fascial dehiscence, Cellulitis, Suture granuloma, Chronic draining sinus, Enterocutaneous fistula, Superficial, deep and organ/space infections, Other
次要结局
- Clinical hernia occurrence/recurrence within 12 months after repair.(12 months)
- Palpability/sensation of suture used for the repair at 12-months follow-up.(12 months)
- Surgeon satisfaction at 1-month follow-up using the 5-point smiley face scale.(1 month)
- Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 12-months follow-up.(12 months)
- SSE within the first 12 months after repair.(12 months)
- Technical success of index-procedure.(Procedure)
- Device performance using the 5-point smiley face scale.(Procedure)
- Return to the operating room (re-interventions) within 12 months for device related issue.(12 months)
- Surgeon satisfaction at index-procedure using the 5-point smiley face scale.(Procedure)
- Quality of life using Short Form 12 (SF-12) health survey at 12-months follow-up.(12 months)
- Patient satisfaction at 1-month follow-up 5-point smiley face scale.(1 month)
- Patient satisfaction at 12-months follow-up 5-point smiley face scale.(12 months)
- Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 1-month follow-up.(1 month)