A Retrospective Breast Reconstruction Study

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.

Official Title
-----------------
A Retrospective, Multi-Center, Open Label Study Evaluating SimpliDerm™ and Other Human Acellular Dermal Matrices in Breast Reconstruction

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: SimpliDerm HADM
* Other: AlloDerm HADM
* Other: AlloMax HADM
* Other: FlexHD HADM
* Other: DermACELL HADM


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SimpliDerm HADM<br>Patients who had SimpliDerm human acellular dermal matrix used in their breast reconstruction procedure. | Other: SimpliDerm HADM<br>* 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.<br>|
| AlloDerm HADM<br>Patients who had AlloDerm human acellular dermal matrix used in their breast reconstruction procedure. | Other: AlloDerm HADM<br>* 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.<br>|
| AlloMax HADM<br>Patients who had AlloMax human acellular dermal matrix used in their breast reconstruction procedure. | Other: AlloMax HADM<br>* 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.<br>|
| FlexHD HADM<br>Patients who had FlexHD human acellular dermal matrix used in their breast reconstruction procedure. | Other: FlexHD HADM<br>* 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.<br>|
| DermACELL HADM<br>Patients who had DermACELL human acellular dermal matrix used in their breast reconstruction procedure. | Other: DermACELL HADM<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |