Status:
COMPLETED
A Retrospective Breast Reconstruction Study
Lead Sponsor:
Elutia Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
Brief Summary
To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.
Detailed Description
This study is a retrospective, multi-center, open label study evaluating SimpliDerm and other human acellular dermal matrices in breast reconstruction. A total of up to 300 patients who underwent dir...
Eligibility Criteria
Inclusion
- Female patient who underwent immediate breast reconstruction post-mastectomy; either direct to implant or with a tissue expander followed by exchange for a saline or gel implant.
- HADMs such as: InteguPly, SimpliDerm, AlloDerm, FlexHD, DermACELL, Cortiva, or AlloMax used in the breast reconstruction.
Exclusion
- Female patient who underwent cosmetic/aesthetic breast augmentation procedure or revision.
- Female patient who underwent delayed breast reconstruction procedure.
- Female patient who underwent revision of previous breast reconstruction procedure.
Key Trial Info
Start Date :
November 20 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT04060134
Start Date
November 20 2019
End Date
June 1 2022
Last Update
February 14 2024
Active Locations (5)
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1
Baptist Medical Center South
Montgomery, Alabama, United States, 36116
2
Shoals Plastic Surgery
Muscle Shoals, Alabama, United States, 35661
3
Tierney Plastic Surgery
Nashville, Tennessee, United States, 37203
4
Ascension/Seton Institute of Reconstructive Plastic Surgery
Austin, Texas, United States, 78731