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Gentrix™ Versus Biological or Prosthetic Mesh

NCT03034213 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-09-29

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    collaborator INDUSTRY

  • University of South Florida

    lead OTHER

Principal Investigators

  • Vic Velanovich, MD · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-06
Primary Completion
2021-06-16
Completion
2021-06-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03034213 on ClinicalTrials.gov