A Retrospective, Multi-Center, Open Label Study Evaluating SimpliDerm™ and Other Human Acellular Dermal Matrices in Breast Reconstruction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aziyo Biologics, Inc.
- Enrollment
- 223
- Locations
- 5
- Primary Endpoint
- Occurrence of Events
Study Overview
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 direct to implant (one stage) or two-stage unilateral or bilateral breast reconstruction with SimpliDerm an other HADMs at the time of implant or TE placement.
Data will be collected for a minimum of one post-surgical visit after direct implant or exchange. If more visits are available, data from those visits will be collected as well.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Occurrence of Events
Time Frame: From date of surgery through study completion, an average of 9 months
Occurrence of: infection, hematoma, seroma, capsular contracture, mastectomy skin flap dehiscence, mastectomy skin flap necrosis, expander/implant explantation, red breast syndrome, subsequent surgical interventions related to the breast reconstruction process
Secondary Outcomes
No secondary outcomes reported