Clinical trial NCT02487628: Evaluation of HQ® Matrix Soft Tissue Mesh for the Treatment of Inguinal Hernia
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Zhejiang Xingyue Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-01
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed clinically as inguinal hernia;
2. Need to be treated with open tension-free hernioplasty;
3. BMI ≤ 40 kg/m\^2;
4. Aged from 18 - 70, male or female;
5. The patients voluntarily signed the subjects' informed consent form.

Exclusion Criteria:

1. Surgeries that cut the gastrointestinal tract or the gastrointestinal tract ruptures accidently;
2. Surgeries that repair the inguinal hernia intraperitoneally;
3. Patients that have done the hernioplasty earlier and undergone multiple recurrence (recurrence rate ≥ 2);
4. The surgical wounds are contaminated;
5. Patients that are treated with coagulant;
6. Patients with serious complication;
7. Patients with pregnancy or lactation;
8. Patients with mental disease including serious hysteria.Do not have legal capacity or have restricted capacity;
9. Those allergic to the test products;
10. Patients that participated other clinical trials in the last 3 months;
11. Patients who, according to other doctors' opinion, are unsuitable to use this material for the treatment.

Primary outcomes:
measure: Postoperative recurrent rate
timeFrame: Day 1 post-operation
measure: Postoperative recurrent rate
timeFrame: Day 3 post-operation
measure: Postoperative recurrent rate
timeFrame: 1 day before hospital discharge
measure: Postoperative recurrent rate
timeFrame: 6 months ± 14 days post-operation
Secondary outcomes:
measure: Number of Participants with Postoperative Complications
timeFrame: Day 1 and day 3 post-operation, 1 day before hospital discharge, and 6 months ± 14 days post-operation
measure: Number of Participants with Discomfort
timeFrame: Day 1 and day 3 post-operation, 1 day before hospital discharge, and 6 months ± 14 days post-operation
measure: Number of Participants with Foreign Body Sensation
timeFrame: Day 1 and day 3 post-operation, 1 day before hospital discharge, and 6 months ± 14 days post-operation
measure: The average hospitalization time
timeFrame: 1 day before hospital discharge
Other outcomes:
Locations:
city: Huanggang
country: China
facility: Huanggang Central Hospital
state: Hubei
city: Huangshi
country: China
facility: Huangshi Central Hospital
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Changsha
country: China
facility: The Forth Hospital of Changsha
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital of Centre-South University
state: Hunan
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
city: Taian
country: China
facility: Taian Chinese Medicine Hospital
state: Shandong
Study officials:
affiliation: Xiangya Hospital of Centre-South University
name: Jianhua Huang
role: PRINCIPAL_INVESTIGATOR
References: