Multi-center, Randomized, Active-controlled, Single-blind, Parallel Two-group Trial of HQ® Matrix Soft Tissue Mesh and ULTRAPRO® Partially Absorbable Lightweight Mesh for the Treatment of Inguinal Hernia
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 7
- 主要终点
- Postoperative recurrent rate
研究概览
简要总结
The purpose of the study is to evaluate the safety and effectiveness of HQ® Matrix Soft Tissue Mesh for the Treatment of Inguinal Hernia. Half of participants will receive HQ® Matrix Soft Tissue Mesh, while the other half will receive ULTRAPRO® Partially Absorbable Lightweight Mesh.
详细描述
HQ® Matrix Soft Tissue Mesh is a warp-knitted, multifilament, bioengineered scaffold which is comprised of the silk fibroin protein of the Bombyx mori (B. mori) silkworm. The porous network structure makes it soft and pliable and convenient to implant. The mesh is mechanically strong, biocompatible, and long-term bioresorbable. The pore size is suitable for macrophage migration and recruitment, which hinders bacteria growth. The mesh is provided in single sheets of varying widths and lengths and may be cut to the shape or size desired for a specific application. It is sterile and for single-patient use only.
ULTRAPRO® Partially Absorbable Lightweight Mesh (Ethicon, Inc.) is manufactured from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non-absorbable polypropylene monofilament fiber. Designed for open and laparoscopic hernia repairs, it allows surgeons the versatility to perform various hernia repairs with a single technology. It offers excellent strength with minimal foreign body mass, to allow patients to heal more naturally with increased comfort and mobility.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed clinically as inguinal hernia;
- •Need to be treated with open tension-free hernioplasty;
- •BMI ≤ 40 kg/m^2;
- •Aged from 18 - 70, male or female;
- •The patients voluntarily signed the subjects' informed consent form.
排除标准
- •Surgeries that cut the gastrointestinal tract or the gastrointestinal tract ruptures accidently;
- •Surgeries that repair the inguinal hernia intraperitoneally;
- •Patients that have done the hernioplasty earlier and undergone multiple recurrence (recurrence rate ≥ 2);
- •The surgical wounds are contaminated;
- •Patients that are treated with coagulant;
- •Patients with serious complication;
- •Patients with pregnancy or lactation;
- •Patients with mental disease including serious hysteria.Do not have legal capacity or have restricted capacity;
- •Those allergic to the test products;
- •Patients that participated other clinical trials in the last 3 months;
- •Patients who, according to other doctors' opinion, are unsuitable to use this material for the treatment.
结局指标
主要结局
Postoperative recurrent rate
时间窗: 6 months ± 14 days post-operation
次要结局
- Number of Participants with Postoperative Complications(Day 1 and day 3 post-operation, 1 day before hospital discharge, and 6 months ± 14 days post-operation)
- Number of Participants with Foreign Body Sensation(Day 1 and day 3 post-operation, 1 day before hospital discharge, and 6 months ± 14 days post-operation)
- Number of Participants with Discomfort(Day 1 and day 3 post-operation, 1 day before hospital discharge, and 6 months ± 14 days post-operation)
- The average hospitalization time(1 day before hospital discharge)