Status:
COMPLETED
Comparing AlloDerm and DermACELL in Breast Reconstruction
Lead Sponsor:
Johns Hopkins University
Conditions:
Acellular Dermal Matrix in Breast Reconstruction
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study will compare 90-day complication rates between breasts reconstructed with tissue expanders and AlloDerm vs. DermACELL, with each patient serving as her own comparator.
Detailed Description
The investigators' study aims to determine if there is a significant difference in postoperative outcomes when using DermACELL or AlloDerm, two acellular dermal matrix products, in breast reconstructi...
Eligibility Criteria
Inclusion
- Female patients over the age of 18
- May be undergoing either therapeutic or prophylactic mastectomy
- Must be undergoing bilateral mastectomy and breast reconstruction with tissue expanders
Exclusion
- Patients who wish to avoid the use of ADM in their reconstruction
- History of radiation of the breast
- Unilateral mastectomies
- Direct to implant breast reconstruction (not utilizing a tissue expander)
Key Trial Info
Start Date :
October 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04710537
Start Date
October 21 2021
End Date
July 26 2022
Last Update
August 4 2022
Active Locations (2)
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1
DAVinci Plastic Surgery
Washington D.C., District of Columbia, United States, 20016
2
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016