A Retrospective Breast Reconstruction Study
A Retrospective, Multi-Center, Open Label Study Evaluating SimpliDerm™ and Other Human Acellular Dermal Matrices in Breast Reconstruction
1 other identifier
observational
223
1 country
5
Brief Summary
To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2019
CompletedFirst Posted
Study publicly available on registry
August 16, 2019
CompletedStudy Start
First participant enrolled
November 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedFebruary 14, 2024
February 1, 2024
2.3 years
August 12, 2019
February 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of Events
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
From date of surgery through study completion, an average of 9 months
Other Outcomes (3)
Integration Assessment
From date of surgery through study completion, an average of 9 months
Drain Removal
From date of surgery through study completion, an average of 9 months
Intraoperative fill volume
From date of surgery through study completion, an average of 9 months
Study Arms (5)
SimpliDerm HADM
Patients who had SimpliDerm human acellular dermal matrix used in their breast reconstruction procedure.
AlloDerm HADM
Patients who had AlloDerm human acellular dermal matrix used in their breast reconstruction procedure.
AlloMax HADM
Patients who had AlloMax human acellular dermal matrix used in their breast reconstruction procedure.
FlexHD HADM
Patients who had FlexHD human acellular dermal matrix used in their breast reconstruction procedure.
DermACELL HADM
Patients who had DermACELL human acellular dermal matrix used in their breast reconstruction procedure.
Interventions
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
Eligibility Criteria
The study population will consist of up to 300 female patients, who had direct to implant or two-stage immediate breast reconstruction following unilateral or bilateral mastectomy surgery.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elutia Inc.lead
Study Sites (5)
Baptist Medical Center South
Montgomery, Alabama, 36116, United States
Shoals Plastic Surgery
Muscle Shoals, Alabama, 35661, United States
Tierney Plastic Surgery
Nashville, Tennessee, 37203, United States
Ascension/Seton Institute of Reconstructive Plastic Surgery
Austin, Texas, 78731, United States
DHR Health
McAllen, Texas, 78504, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2019
First Posted
August 16, 2019
Study Start
November 20, 2019
Primary Completion
March 14, 2022
Study Completion
June 1, 2022
Last Updated
February 14, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share