NCT04060134

A Retrospective Breast Reconstruction Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 223 (actual)
• Sponsor: Elutia Inc. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.
OTHER	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.
OTHER	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.
OTHER	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.
OTHER	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.

Timeline

• Start date: 2019-11-20
• Primary completion: 2022-03-14
• Completion: 2022-06-01
• First posted: 2019-08-16
• Last updated: 2024-02-14

Locations

5 sites across 1 country: United States