Retrospective Analysis of Veritas in Breast Reconstruction

Completed

• Conditions: Seroma; Infection; Necrosis

• Registration Number: NCT01454713
• Lead Sponsor: Baxter Healthcare Corporation

Brief Summary

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

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 Timeline

• Study Start: 2010-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2011-10-17
• Study First Submitted QC: 2011-10-17
• Study First Posted: 2011-10-19
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Mark M. Mofid, MD; 🇺🇸 San Diego, California, United States

Michael Meininger, MD; 🇺🇸 Troy, Michigan, United States

Martin Lacey, MD; 🇺🇸 St. Paul, Minnesota, United States