NCT03911700进行中（未招募）不适用
Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy
C. R. Bard119 个研究点 分布在 5 个国家目标入组 477 人开始时间: 2019年12月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 477
- 试验地点
- 119
- 主要终点
- Rate of Incisional Hernia
研究概览
简要总结
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery.
详细描述
Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.
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
- •Must be ≥ 18 years of age
- •Elective, open midline laparotomy ≥ 5 cm
- •Willing and able to provide written informed consent
- •Hernia risk equal to moderate or greater
排除标准
- •Previous hernia repair
- •Emergent surgery
- •Creation of skin flaps is preplanned
- •Preplanned 2nd surgery
- •Active skin pathology
- •Life expectancy less than 24 months
- •Pregnant or planning to become pregnant
- •Receiving a medication/medical condition that may adversely affect wound healing
- •ASA Class > IV
- •Enrolled in another clinical trial
- •Site personnel directly involved with this trial
- •Any condition that would preclude the use of the device or the subject form completing the follow-up requirements
- •Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
- •Two separate incisions are created
- •Prior onlay mesh
- •Surgeon is unable to fully close the fascia
- •The surgery requires more than a single piece of mesh
- •Contraindication to placement of mesh
- •CDC Class IV/Active Infection
- •Breastfeeding
研究组 & 干预措施
Phasix™ Mesh
Experimental
Prophylactic onlay placement of mesh.
干预措施: Phasix™ Mesh (Device)
Primary Suture Closure
No Intervention
Standard Fascial closure.
结局指标
主要结局
Rate of Incisional Hernia
时间窗: 24-Months
The primary endpoint of the trial is the occurrence of incisional hernia in each treatment group (Phasix™ Mesh or Control Group)
次要结局
- Rate of Device-related Adverse Events (AEs)(60-Months)
- Length of surgical procedure in minutes(Study Day 0)
- Quality of Life: Optum Short Form Survey 12 Item Version 2 (SF-12v2®)(60-Months)
- Quality of Life: EuroQoL-5 Dimensions-3 Level (EQ-5D-3L©)(60-months)
- Rate of Incisional Hernia(60-Months)
- Length of time for wound closure in minutes(Study Day 0)
- Length of hospital stay in days(Through hospital stay, typically 3 days)
研究者
研究点 (119)
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