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