Retrospective Analysis of Veritas in Breast Reconstruction (RAVE)

Retrospective Analysis of Veritas in Breast Reconstruction (RAVE)

Retrospective data collection of the use of Veritas in breast reconstruction surgery

Study Overview

• Status: Completed
• Conditions: Necrosis; Infection; Seroma

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
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • Mark M. Mofid, MD
  • Michigan
    • Troy, Michigan, United States, 48084
      • Michael Meininger, MD
  • Minnesota
    • St. Paul, Minnesota, United States, 55101
      • Martin Lacey, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who have undergone single-stage or two-stage breast reconstruction surgery with Veritas

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Veritas; Breast reconstruction with Veritas

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Synovis Surgical Innovations
• Investigators: Principal Investigator: Mark M Mofid, MD, UCSD

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: October 17, 2011
• First Submitted That Met QC Criteria: October 17, 2011
• First Posted (Estimate): October 19, 2011

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: 10-001