Poly-4-hydroxybutyrate Mesh Versus Current Care of Complex Open Ventral Hernias: A Multi-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Major complication free
研究概览
简要总结
The purpose of this study is to compare clinical and patient centered outcomes of biosynthetic poly-4-hydroybutyrate meshes versus current care (synthetic polypropylene mesh or suture) for complex ventral hernia repair. The primary outcome for this study will be patients who are major complication free at 2 years postoperative. This will be a composite of hernia recurrence, reoperation, chronic wound complication, or death. Secondary outcomes include: surgical site occurences such as surgical site infection, seroma, hematoma and skin dehiscence within 90 days postoperative, emergency room visits withing 90 days postoperative, days in hospital up to 90 days postoperative, abdominal pain, and change in patient centered outcomes measured through the modified activities assessment scale (mAAS).
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
- Double (Participant, Outcomes Assessor)
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
- •Adult patients (18 years or older) with a complex ventral hernia scheduled for repair
排除标准
- •Patients likely to die within 3 years (cirrhosis, terminal cancer, surgeon judgement)
- •Unlikely to follow-up (live out of state, unable to be reached by phone or email)
- •Non-English and non-Spanish speakers
- •Pregnant or breast-feeding patients
- •Allergies/hypersensitivities to tetracycline hydrochloride and kanamycin sulfate
结局指标
主要结局
Major complication free
时间窗: 2 years post-operative
A composite of hernia recurrence, reoperation, chronic wound complication, or death
次要结局
- Surgical site occurrences(90 days post-operative)
- Hospital duration(90 days post-operative)
- Post-operative abdominal pain(Day of consent and post-operatively at 1 month, 1 year and 2 years)
- Clavien-Dindo complication grade(90 days post-operative)
- Emergency room visits(90 days post-operative)
- Cost Analysis(2 years)
- Patient centered outcomes(Day of consent and post-operatively at 1 month, 1 year and 2 years)
研究者
Julie Holihan
Assistant Professor of Surgery-Clinical
The University of Texas Health Science Center, Houston