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

Not Applicable

• Conditions: Inguinal Hernia
• Interventions: Device: ULTRAPRO® Partially Absorbable Lightweight Mesh; Device: HQ® Matrix Soft Tissue Mesh

• Registration Number: NCT02487628
• Lead Sponsor: Zhejiang Xingyue Biotechnology Co., Ltd.

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.

Study Timeline

• Study Start: 2014-11
• Status Verified: 2015-06
• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-06-29
• Last Update Submitted: 2015-06-29
• Study First Posted: 2015-07-01
• Last Update Posted: 2015-07-01
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ULTRAPRO® Partially Absorbable Lightweight Mesh	ULTRAPRO® Partially Absorbable Lightweight Mesh	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.
HQ® Matrix Soft Tissue Mesh	HQ® Matrix Soft Tissue Mesh	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.

Primary Outcome Measures

Name	Time	Method
Postoperative recurrent rate	6 months ± 14 days post-operation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Xiangya Hospital of Centre-South University; 🇨🇳 Changsha, Hunan, China

Huangshi Central Hospital; 🇨🇳 Huangshi, Hubei, China

Huanggang Central Hospital; 🇨🇳 Huanggang, Hubei, China

The Forth Hospital of Changsha; 🇨🇳 Changsha, Hunan, China

Xiangyang Central Hospital; 🇨🇳 Xiangyang, Hubei, China

Xiangtan Central Hospital; 🇨🇳 Xiangtan, Hunan, China

Taian Chinese Medicine Hospital; 🇨🇳 Taian, Shandong, China