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RECRUITING
NCT04661501
NA

BREAST ADM Trial for Alloplastic Breast Reconstruction

Sponsor: University of British Columbia

View on ClinicalTrials.gov

Summary

This study is a randomized single blinded prospective clinical trial comparing the surgical outcomes of four different acellular dermal matrixes (ADMs) after primary breast reconstruction. ADMs are used in conjunction with tissue expanders or breast implants to reinforce the recreated breast pocket. Currently, 4 different ADMS are commercially available: AlloDerm, DermaCell, Allomax and Flex HD. It is unclear which ADM is clinically superior. The objective of the study is to compare the complications and post-op care of 4 different ADMs within a 2 year follow up to elucidate their surgical outcomes.

Official title: The BREAST Trial: A Randomized, Non-inferiority, Study Comparing the Complication Profile of Four Commercially Available Acellular Dermal Matrixes Used in Alloplastic Breast Reconstruction

Key Details

Gender

FEMALE

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

328

Start Date

2020-11-25

Completion Date

2025-12-31

Last Updated

2024-12-16

Healthy Volunteers

No

Interventions

DEVICE

AlloDerm

Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.

DEVICE

AlloMax

Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.

DEVICE

DermACELL

Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.

DEVICE

Flex HD

Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.

Locations (4)

Mount Saint Joseph's Hospital

Vancouver, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

UBC Hospital

Vancouver, British Columbia, Canada

Saint Paul's Hospital

Vancouver, British Columbia, Canada