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Multi-Center Study To Examine The Use Of Flex HD® And Strattice In The Repair Of Large Abdominal Wall Hernias

NCT01987700 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-09-19

No results posted yet for this study

Summary

The primary objective of this study is to examine and compare the outcomes associated with the use of Flex HD®, a human acellular dermal matrix (HADM), and Strattice™, a porcine acellular dermal matrix, (PADM) when used as a reinforcing material in the repair of large complicated abdominal wall hernias.

Conditions

  • Hernia of Abdominal Wall

Interventions

DEVICE

FLEX-HD

DEVICE

Strattice

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER

  • Pines Surgical

    collaborator UNKNOWN

  • Meridian Healthcare System

    collaborator UNKNOWN

  • Musculoskeletal Transplant Foundation

    lead OTHER

Principal Investigators

  • Grant Bochicchio, MD, MPH · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2018-06-30
Completion
2018-08-25

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 NCT01987700 on ClinicalTrials.gov