Status:
TERMINATED
The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Mastectomy
Postoperative Pain
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This study intends to compare postoperative outcomes of a tissue expander placement following a mastectomy with two different operative techniques. This study will be randomized and double blinded com...
Eligibility Criteria
Inclusion
- Patients presenting to Dr. Wendel's clinic who are older than 17 years of age undergoing a mastectomy and wish to have breast reconstruction with a tissue expander or those who have previously undergone a mastectomy and are now seeking reconstruction will be solicited for the study.
Exclusion
- Preoperative radiation therapy
- Autoimmune disease
- Fever
- Uncontrolled diabetes mellitus
- Inability to comprehend or cooperate with postoperative instructions
- Local or systemic infection
- Have any allergies to the excipient ingredients found in the matrix
- Pregnancy
- Low vascularity of the surrounding tissue
- Mechanical trauma
- Poor nutrition
- Poor general medical condition
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00616824
Start Date
September 1 2007
End Date
March 1 2010
Last Update
April 4 2017
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2345