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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HQ® Matrix Soft Tissue Mesh | Experimental | 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. |
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| ULTRAPRO® Partially Absorbable Lightweight Mesh | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HQ® Matrix Soft Tissue Mesh | Device |
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| |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongxu Yang | Contact | +86-13488696229 |
| Name | Affiliation | Role |
|---|---|---|
| Jianhua Huang | Xiangya Hospital of Centre-South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huanggang Central Hospital | Recruiting | Huanggang | Hubei | 438000 | China |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ULTRAPRO® Partially Absorbable Lightweight Mesh |
| Device |
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| 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 |
| Huangshi Central Hospital | Recruiting | Huangshi | Hubei | 435000 | China |
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| Xiangyang Central Hospital | Recruiting | Xiangyang | Hubei | 441021 | China |
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| The Forth Hospital of Changsha | Recruiting | Changsha | Hunan | 410006 | China |
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| Xiangya Hospital of Centre-South University | Recruiting | Changsha | Hunan | 410008 | China |
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| Xiangtan Central Hospital | Recruiting | Xiangtan | Hunan | China |
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| Taian Chinese Medicine Hospital | Recruiting | Taian | Shandong | China |
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