Gentrix™ Versus Biological or Prosthetic Mesh

NATerminatedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

October 6, 2017

Primary Completion Date

June 16, 2021

Study Completion Date

June 16, 2021

Conditions
Ventral Incisional Hernia
Interventions
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.

Trial Locations (3)

33606

Tampa General Hospital, Tampa

University of South Florida - South Tampa Campus, Tampa

33612

University of South Florida Morsani Center for Advanced Health Care, Tampa

Sponsors
All Listed Sponsors
collaborator

Integra LifeSciences Corporation

INDUSTRY

lead

University of South Florida

OTHER