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The Use of An Acellular Dermal Matrix Sling in a Two-stage Breast REconstruciton After Mastectomy: A Double-blinded Randomized Trial


N/A
18 Years
75 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

The Use of An Acellular Dermal Matrix Sling in a Two-stage Breast REconstruciton After Mastectomy: A Double-blinded Randomized Trial


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.


Inclusion Criteria:



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

Exclusion Criteria:

- Other forms of breast reconstruction after mastectomy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Patient satisfaction with the procedure

Outcome Time Frame:

one year from time of operation

Safety Issue:

No

Principal Investigator

Jason Wendel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt University

Authority:

United States: Institutional Review Board

Study ID:

070416

NCT ID:

NCT00692692

Start Date:

June 2007

Completion Date:

December 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Vanderbilt University Medical CenterNashville, Tennessee  37232-2516