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Retrospective Analysis of Veritas in Breast Reconstruction (RAVE)

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ClinicalTrials.gov Identifier: NCT01454713
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
Synovis Surgical Innovations
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Brief Summary:
Retrospective data collection of the use of Veritas in breast reconstruction surgery

Condition or disease
Seroma Necrosis Infection

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.

Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Analysis of Veritas in Breast Reconstruction (RAVE)
Study Start Date : October 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Veritas
Breast reconstruction with Veritas




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

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

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

Additional relevant MeSH terms:
Necrosis
Pathologic Processes