NCT03034213

Gentrix™ Versus Biological or Prosthetic Mesh

Randomized, Controlled Trial Comparing Separation of Components Repair With Retrorectus Gentrix™ Surgical Matrix Versus Biological or Prosthetic Mesh for Open Ventral Hernia Repair

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis for this study is complex incisional hernia repair using the separation of components technique reinforced with retrorectus placement of Gentrix™ Surgical Matrix will lead to fewer incisional hernia recurrences and fewer wound complications compared to the same incisional hernia repair techniques reinforced with other prosthetic or biologically-derived mesh.

Detailed description

Biological and prosthetic mesh products are extensively used in hernia repairs. However, they also have their limitations. Potential complications associated with prosthetic mesh for hernia repairs include: adverse reactions to the mesh, mesh erosion, stricture formation, adhesions resulting in bowel obstruction, enterocutaneous fistulas, injuries to nearby organs, nerves or blood vessels, infection, chronic pain and hernia recurrence. Potential complications associated with biological mesh include: adverse inflammatory response, laxity, eventration, and recurrent herniation. This study is a two-arm, randomized, controlled trial comparing separation of components repair with retrorectus Gentrix™ Surgical Matrix versus biological or prosthetic mesh for open ventral hernia repair.

Conditions

• Ventral Incisional Hernia

Interventions

Type	Name	Description
DEVICE	Gentrix™ Surgical Matrix (Treatment)	Gentrix™ Surgical Matrix will be placed in the retrorectus space. The anterior midline fascia will be closed with long-acting absorbable suture either with a running or interrupted manner as per the surgeon's discretion.
DEVICE	Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend (Control)	A biological or prosthetic mesh (Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend) will be placed in the retrorectus space. The anterior midline fascia will be closed with long-acting absorbable suture either with a running or interrupted manner as per the surgeon's discretion.

Timeline

• Start date: 2017-10-06
• Primary completion: 2021-06-16
• Completion: 2021-06-16
• First posted: 2017-01-27
• Last updated: 2021-09-29

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study