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

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

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.

Study Overview

• Status: Unknown
• Conditions: Inguinal Hernia
• Intervention / Treatment: Device: HQ® Matrix Soft Tissue Mesh; Device: 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 Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yongxu Yang; Phone Number: +86-13488696229

Study Locations

• China
  • Hubei
    • Huanggang, Hubei, China, 438000
      • Recruiting
      • Huanggang Central Hospital
      • Contact: Youneng Yuan; Phone Number: +86-15971530385
    • Huangshi, Hubei, China, 435000
      • Recruiting
      • Huangshi Central Hospital
      • Contact: Youneng Yuan; Phone Number: 15971530385
    • Xiangyang, Hubei, China, 441021
      • Recruiting
      • Xiangyang Central Hospital
      • Contact: Dejie Chen; Phone Number: +86-13995743892
  • Hunan
    • Changsha, Hunan, China, 410006
      • Recruiting
      • The Forth Hospital of Changsha
      • Contact: Guohuang Hu; Phone Number: +86-13908452960
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Xiangya Hospital of Centre-South University
      • Contact: Jianhua Huang; Phone Number: +86-13507319258
    • Xiangtan, Hunan, China
      • Recruiting
      • Xiangtan Central Hospital
      • Contact: Shaojie Li; Phone Number: +86-13327320903
  • Shandong
    • Taian, Shandong, China
      • Recruiting
      • Taian Chinese Medicine Hospital
      • Contact: Yuejie Chen; Phone Number: +86-18653891638

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: HQ® Matrix Soft Tissue Mesh; Other Names: HQ® Matrix
Active Comparator: 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.	Device: ULTRAPRO® Partially Absorbable Lightweight Mesh; Other Names: ULTRAPRO®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Zhejiang Xingyue Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Jianhua Huang, Xiangya Hospital of Centre-South University

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: June 26, 2015
• First Submitted That Met QC Criteria: June 29, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Estimate): July 1, 2015
• Last Update Submitted That Met QC Criteria: June 29, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: YL-QX-YYZZBP-2014