Retrospective Analysis of Veritas in Breast Reconstruction

Infection Clinical Trial

— RAVE  

Official title:

Retrospective Analysis of Veritas in Breast Reconstruction (RAVE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454713
• Other study ID #: 10-001
• Status: Completed
• Phase: N/A
• First received: October 17, 2011
• Last updated: April 4, 2017
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Necrosis
• Seroma

Locations

Country	Name	City	State
United States	Mark M. Mofid, MD	San Diego	California
United States	Martin Lacey, MD	St. Paul	Minnesota
United States	Michael Meininger, MD	Troy	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Synovis Surgical Innovations

Country where clinical trial is conducted

United States,