Use of Dermal Matrix in Breast Reconstruction

Not Applicable

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT00692692
• Lead Sponsor: Vanderbilt University

Brief Summary

We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.

Detailed Description

We propose a double blinded, randomized study of 60 women comparing outcomes which will include postoperative pain, complication rates and aesthetic outcome as assessed by the patient and a plastic surgeon blinded to the method of reconstruction.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2013-08-03
• Results First Submitted QC: 2013-08-03
• Results First Posted: 2013-10-11
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• All women who are candidates for breast reconstruction using tissue expanders after mastectomy

Exclusion Criteria

• Other forms of breast reconstruction after mastectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Post Surgical Infection	4 weeks	Number of participants with post surgical infection
Patient Satisfaction With the Procedure	one year from time of operation

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States