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Retrospective Analysis of Veritas in Breast Reconstruction (RAVE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01454713
First Posted: October 19, 2011
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Synovis Surgical Innovations
Information provided by (Responsible Party):
Baxter Healthcare Corporation
  Purpose
Retrospective data collection of the use of Veritas in breast reconstruction surgery

Condition
Seroma Necrosis Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Analysis of Veritas in Breast Reconstruction (RAVE)

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Enrollment: 54
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Veritas
Breast reconstruction with Veritas

Detailed Description:
This is a multi-center study to retrospectively collect data on the use of Veritas Collagen Matrix in breast reconstruction. Data will be collected on post-operative complications in immediate breast reconstruction and then be compared to literature reported post-operative complication rates associated with the use of acellular dermal matrix in immediate breast reconstruction.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients who have undergone single-stage or two-stage breast reconstruction surgery with Veritas
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Patients who underwent mastectomy with immediate breast reconstruction using Veritas collagen matrix
  • Patients who underwent mastectomy with single stage procedures or two-stage procedures using Veritas collagen matrix

Exclusion Criteria:

  • Patients who underwent delayed breast reconstruction
  • Reconstruction with something other than Veritas collagen matrix
  • Breasts that were created with DIEP or TRAM procedures
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454713


Locations
United States, California
Mark M. Mofid, MD
San Diego, California, United States, 92037
United States, Michigan
Michael Meininger, MD
Troy, Michigan, United States, 48084
United States, Minnesota
Martin Lacey, MD
St. Paul, Minnesota, United States, 55101
Sponsors and Collaborators
Baxter Healthcare Corporation
Synovis Surgical Innovations
Investigators
Principal Investigator: Mark M Mofid, MD UCSD
  More Information

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01454713     History of Changes
Other Study ID Numbers: 10-001
First Submitted: October 17, 2011
First Posted: October 19, 2011
Last Update Posted: April 5, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Necrosis
Pathologic Processes