Breast Cancer
Conditions
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.
Interventions
OTHERSimpliDerm HADM
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.
OTHERAlloDerm HADM
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.
OTHERAlloMax HADM
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.
OTHERFlexHD HADM
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.
OTHERDermACELL HADM
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.
Sponsors
Elutia Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Events | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Integration Assessment | From date of surgery through study completion, an average of 9 months | Integration assessment for patients with two-stage reconstruction at time of exchange, if available, via surgeon's operative notes |
| Drain Removal | From date of surgery through study completion, an average of 9 months | Time to drain removal and volume of fluid drained, if available |
| Intraoperative fill volume | From date of surgery through study completion, an average of 9 months | Intraoperative fill volume |
Countries
United States
Outcome results
None listed