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Retrospective Analysis of Veritas in Breast Reconstruction (RAVE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synovis Surgical Innovations
ClinicalTrials.gov Identifier:
NCT01454713
First received: October 17, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  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:

U.S. FDA Resources

Further study details as provided by Synovis Surgical Innovations:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Synovis Surgical Innovations
Investigators
Principal Investigator: Mark M Mofid, MD UCSD
  More Information

No publications provided

Responsible Party: Synovis Surgical Innovations
ClinicalTrials.gov Identifier: NCT01454713     History of Changes
Other Study ID Numbers: 10-001
Study First Received: October 17, 2011
Last Updated: October 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Necrosis
Seroma
Pathologic Processes
Inflammation

ClinicalTrials.gov processed this record on May 23, 2013