A Retrospective Breast Reconstruction Study

Aziyo Biologics

Status: Completed

Conditions: Breast Cancer

Treatments: Other: DermACELL HADM; Other: AlloMax HADM; Other: SimpliDerm HADM; Other: FlexHD HADM; Other: AlloDerm HADM

Study type: Observational

Funder types: Industry

Identifiers

NCT04060134

CLP-0004

Details and patient eligibility

About

To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.

Full 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.

Enrollment: 223 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

223 participants in 5 patient groups

SimpliDerm HADM

Description:

Patients who had SimpliDerm human acellular dermal matrix used in their breast reconstruction procedure.

Treatment:

Other: SimpliDerm HADM

AlloDerm HADM

Description:

Patients who had AlloDerm human acellular dermal matrix used in their breast reconstruction procedure.

Treatment:

Other: AlloDerm HADM

AlloMax HADM

Description:

Patients who had AlloMax human acellular dermal matrix used in their breast reconstruction procedure.

Treatment:

Other: AlloMax HADM

FlexHD HADM

Description:

Patients who had FlexHD human acellular dermal matrix used in their breast reconstruction procedure.

Treatment:

Other: FlexHD HADM

DermACELL HADM

Description:

Patients who had DermACELL human acellular dermal matrix used in their breast reconstruction procedure.

Treatment:

Other: DermACELL HADM