A Retrospective Breast Reconstruction Study

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04060134
• Other study ID #: CLP-0004
• Status: Completed
• Start date: November 20, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2024
• Source: Aziyo Biologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: June 1, 2022
• Est. primary completion date: March 14, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• SimpliDerm 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.
• AlloDerm 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.
• AlloMax 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.
• FlexHD 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.
• DermACELL 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.

Locations

Country	Name	City	State
United States	Ascension/Seton Institute of Reconstructive Plastic Surgery	Austin	Texas
United States	DHR Health	McAllen	Texas
United States	Baptist Medical Center South	Montgomery	Alabama
United States	Shoals Plastic Surgery	Muscle Shoals	Alabama
United States	Tierney Plastic Surgery	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Aziyo Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Integration Assessment	Integration assessment for patients with two-stage reconstruction at time of exchange, if available, via surgeon's operative notes	From date of surgery through study completion, an average of 9 months
Other	Drain Removal	Time to drain removal and volume of fluid drained, if available	From date of surgery through study completion, an average of 9 months
Other	Intraoperative fill volume	Intraoperative fill volume	From date of surgery through study completion, an average of 9 months
Primary	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

External Links

•   Aziyo Biologics, Inc.