Evaluation of HQ® Matrix Soft Tissue Mesh for the Treatment of Inguinal Hernia

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Device: HQ® Matrix Soft Tissue Mesh
* Device: ULTRAPRO® Partially Absorbable Lightweight Mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HQ® Matrix Soft Tissue Mesh<br>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. | Device: HQ® Matrix Soft Tissue Mesh<br> <br> * Other names: HQ® Matrix;|
| Active Comparator: ULTRAPRO® Partially Absorbable Lightweight Mesh<br>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. | Device: ULTRAPRO® Partially Absorbable Lightweight Mesh<br> <br> * Other names: ULTRAPRO®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative recurrent rate |  | Day 1 post-operation | 
| Postoperative recurrent rate |  | Day 3 post-operation | 
| Postoperative recurrent rate |  | 1 day before hospital discharge | 
| Postoperative recurrent rate |  | 6 months ± 14 days post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Discomfort |  | 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 | 
| The average hospitalization time |  | 1 day before hospital discharge |