Use of Biological Mesh Versus Standard Wound Care in Infected Incisional Ventral Hernias: a Multicenter Randomized Controlled Trial, the SIMBIOSE Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- 6-month postoperative morbidity
研究概览
简要总结
The SIMBIOSE trial is a large multicenter phase III prospective randomized controlled single blinded trial comparing the use of biological mesh versus traditional wound care without biological mesh in patients with an infected incisional ventral hernia. The primary endpoint is 6-month infectious and/or wound morbidity. Secondary endpoints are wound infection rate at 45 days, 3 months and 1 year, recurrent hernia rates at 1, 2 and 3 years, postoperative pain, quality of life, time to healing, need for wound reoperation, impact of the cross-linked mesh structure, and medico-economic evaluation. One hundred patients need to be included.
详细描述
Comparison between standard wound care and the use of biological meshes in infected fields
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
- Single (Participant)
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
- •wound infection related to a synthetic non-absorbable mesh for at least 15 days duration
- •incisional abdominal hernia with an abcess or fistula, without the presence of a synthetic non-absorbable mesh
- •incisional abdominal hernias smaller than 20 centimeter in the 2 largest diameters
- •incisional abdominal hernias requiring a surgical procedure
- •incisional abdominal hernias amenable to repair with a single biological mesh
- •age over 18 years
排除标准
- •non-infected incisional abdominal hernia
- •history of biological mesh placement
- •incisional abdominal hernia in contaminated, but non infected field (stoma presence, violation of gastrointestinal tract)
- •incisional abdominal hernia larger than 20 x 20 cm
- •BMI ≥ 40 kg/m2
- •ASA score 4 and 5
- •immunosuppression (including steroid and cytotoxic therapy)
- •chronic disease such as cirrhosis, renal insufficiency with renal dialysis, malignant disease, known collagen disorder
- •life expectancy under than 36 months
- •allergy to one of the biological mesh components
- •pregnancy or breastfeeding
研究组 & 干预措施
biological mesh
patients will undergo the implantation of a biological mesh (after debridement and treatment of the infection) at the same time as the primary operation, or within one month of randomization.
干预措施: Biological mesh (Biological)
without biological mesh
patients undergo traditional wound care (debridement and treatment of infection), without placement of a biological mesh. For arm B, the common wound care used follows the normal practice of the treating surgeon, except the placement of the biological mesh, which must not be performed within 6 months of randomization.
干预措施: without biological mesh (Procedure)
结局指标
主要结局
6-month postoperative morbidity
时间窗: 6 months
次要结局
- time to cure(up to 3 years)
- need for wound reoperation due to infection or hernia recurrence(up to 3 years)
- Day 45 wound infection rate(45 days)
- 3 months wound infection rate(3 months)
- 1 year wound infection rate(1 year)
- impact of the cross-linked mesh structure on the 1-year recurrence rate(1 year)
- impact of the cross-linked mesh structure on the 3-year recurrence rate(3 years)
- impact of the cross-linked mesh structure on the primary objective(6 months)
- postoperative pain(up to 3 years)
- 2-year recurrent hernia rates(2 years)
- 3-year recurrent hernia rates(3 years)
- 1-year recurrent hernia rates(1 year)
- quality of life(up to 3 years)
- medico-economic evaluation taking into account direct costs related to infected ventral hernia treatment.(up to 3 years)
- impact of the cross-linked mesh structure on the 1-year infection rate(1 year)