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

Zhejiang Xingyue Biotechnology

Status: Unknown

Conditions: Inguinal Hernia

Treatments: Device: ULTRAPRO® Partially Absorbable Lightweight Mesh; Device: HQ® Matrix Soft Tissue Mesh

Study type: Interventional

Funder types: Industry

Identifiers

NCT02487628

YL-QX-YYZZBP-2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

HQ® Matrix Soft Tissue Mesh

Experimental group

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.

Treatment:

Device: HQ® Matrix Soft Tissue Mesh

ULTRAPRO® Partially Absorbable Lightweight Mesh

Active Comparator group

Description:

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.

Treatment:

Device: ULTRAPRO® Partially Absorbable Lightweight Mesh