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

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02487628
• Other study ID #: YL-QX-YYZZBP-2014
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2015
• Last updated: June 29, 2015
• Start date: November 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: Zhejiang Xingyue Biotechnology Co., Ltd.
• Contact: Yongxu Yang
• Phone: +86-13488696229
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Device:
• HQ® Matrix Soft Tissue Mesh

• ULTRAPRO® Partially Absorbable Lightweight Mesh

Locations

Country	Name	City	State
China	The Forth Hospital of Changsha	Changsha	Hunan
China	Xiangya Hospital of Centre-South University	Changsha	Hunan
China	Huanggang Central Hospital	Huanggang	Hubei
China	Huangshi Central Hospital	Huangshi	Hubei
China	Taian Chinese Medicine Hospital	Taian	Shandong
China	Xiangtan Central Hospital	Xiangtan	Hunan
China	Xiangyang Central Hospital	Xiangyang	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Xingyue Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative recurrent rate		Day 1 post-operation	Yes
Primary	Postoperative recurrent rate		Day 3 post-operation	Yes
Primary	Postoperative recurrent rate		1 day before hospital discharge	Yes
Primary	Postoperative recurrent rate		6 months ± 14 days post-operation	Yes
Secondary	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	Yes
Secondary	Number of Participants with Discomfort		Day 1 and day 3 post-operation, 1 day before hospital discharge, and 6 months ± 14 days post-operation	Yes
Secondary	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	Yes
Secondary	The average hospitalization time		1 day before hospital discharge	No