Gentrix™ Versus Biological or Prosthetic Mesh

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03034213
Study type	Interventional
Source	University of South Florida
Contact
Status	Terminated
Phase	N/A
Start date	October 6, 2017
Completion date	June 16, 2021

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT06306976` - Shear-Wave Elastography	N/A
Not yet recruiting	`NCT06183840` - Only Mesh Fixation With Glue of Ventral/Incisional Laparoscopic Hernia Repair	N/A
Completed	`NCT02206828` - The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
Not yet recruiting	`NCT04624100` - Quality Control of Ventral Hernia Surgery by Prospective Registration
Active, not recruiting	`NCT03324854` - Use of Mosquito Net Mesh for Ventral Hernia Repair	N/A
Not yet recruiting	`NCT05575141` - Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias	N/A
Completed	`NCT01325792` - Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement	N/A
Terminated	`NCT03317665` - Observational Biologic or Prosthetic Mesh
Recruiting	`NCT05576753` - Preperitoneal Umbilical Mesh Area	N/A
Completed	`NCT05142761` - Tension in Posterior Component Separation for Abdominal Wall Reconstruction
Recruiting	`NCT03255239` - Open Preperitoneal Mesh Versus Retromuscular Mesh Versus Suture Repair for Abdominal Wall Hernias	N/A
Completed	`NCT03043079` - Ultrasound Assessment of Ventral Hernia Defects	N/A
Completed	`NCT02129140` - Observational Study to Evaluate Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign)