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
1 other identifier
interventional
144
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 26, 2015
CompletedFirst Posted
Study publicly available on registry
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 1, 2015
June 1, 2015
1.6 years
June 26, 2015
June 29, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
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
Study Arms (2)
HQ® Matrix Soft Tissue Mesh
EXPERIMENTALHQ® 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
ACTIVE COMPARATORULTRAPRO® 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Huanggang Central Hospital
Huanggang, Hubei, 438000, China
Huangshi Central Hospital
Huangshi, Hubei, 435000, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441021, China
The Forth Hospital of Changsha
Changsha, Hunan, 410006, China
Xiangya Hospital of Centre-South University
Changsha, Hunan, 410008, China
Xiangtan Central Hospital
Xiangtan, Hunan, China
Taian Chinese Medicine Hospital
Taian, Shandong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianhua Huang
Xiangya Hospital of Centre-South University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2015
First Posted
July 1, 2015
Study Start
November 1, 2014
Primary Completion
June 1, 2016
Study Completion
December 1, 2016
Last Updated
July 1, 2015
Record last verified: 2015-06