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A Comparison of Fortiva and Strattice Tissue Matrices in Complex, Ventral Hernia Repair

NCT02587403 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-12-27

Study results available
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Summary

The objective of this study is to compare the effectiveness of Fortiva Porcine Dermis versus Strattice Reconstructive Tissue Matrix for the underlay reinforcement of complex ventral hernia repair and assess post-operative complication rates, long term hernia recurrence rates.

Conditions

  • Ventral Hernia

Interventions

DEVICE

Fortiva™ Porcine Dermis

Fortiva Porcine Dermis implantation during repair of complex ventral hernia

DEVICE

Strattice™ Reconstructive Tissue Matrix

Strattice tissue matrix implanted during repair of complex ventral hernia

Sponsors & Collaborators

  • RTI Surgical

    lead INDUSTRY

Principal Investigators

  • Grant Bochicchio, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-02
Primary Completion
2023-09-19
Completion
2023-09-19

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 NCT02587403 on ClinicalTrials.gov