Acellular Dermal Matrix Investigation in Breast Reconstruction

Purpose

Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.

Condition

  • Breast Reconstruction

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Genetic female - Age 22 or older at time of consent - Undergoing immediate breast reconstruction - 2 stage breast reconstruction using pre pectoral technique - Nipple or skin sparing mastectomy - Willing and capable of providing informed consent - Able to comply with study requirements

Exclusion Criteria

  • Planned concurrent reconstruction with pedicled flaps or free tissue - Pregnant or breast feeding - Investigator has determined tissue is unsuitable for two-stage breast reconstruction - History of psychological characteristics that may be incompatible with the surgical procedure and the prosthesis - Any serious and/or unstable pre-existing medical disorder or other conditions that could interfere with the subject's safety, the informed consent process, or compliance with the study protocol, in the opinion of the investigator - Vulnerable subject populations - Currently participating in another clinical trial that would have the potential to interfere or conflict with the treatment, follow-up, or objectives of this study - Prior history of neoadjuvant radiotherapy to the reconstruction site or chest wall - Active abscess or infection in the intended reconstruction site - Residual gross tumor at the intended reconstruction site - Active use of any tobacco/nicotine products - Has body mass index (BMI) >35 - Uncontrolled diabetes defined as HbA1c ≥7 within 3 months prior to stage 1 procedure - Is currently taking medications including systemic steroids - Is scheduled to undergo post-operative radiation therapy

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Acellular Dermal Matrix 		Breast reconstruction with Cortiva Tissue Matrix
  • Device: Acellular Dermal Matrix (Cortiva Tissue Matrix)
    non-crosslinked dermis
No Intervention
no Acellular Dermal Matrix 		Breast reconstruction only with no ADM

Recruiting Locations

City of Hope National Medical Center
Duarte 5344147, California 5332921 91010
Contact:
Sarah Taylor

University of Colorado
Aurora 5412347, Colorado 5417618 80045
Contact:
Mamadou Seye
mamadou.seye@cuanschutz.edu

Washington University
St Louis 4407066, Missouri 4398678 63110
Contact:
Aliyah Thomas
aliyaht@wustl.edu

Mercy Hospital
St Louis 4407066, Missouri 4398678 63141
Contact:
Brenna Reilly
Brenna.Reilly@mercy.net

NYU Langone Health
New York 5128581, New York 5128638 10016
Contact:
Brooke Miller
brooke.miller@nyulangone.org

Columbia University Irving Medical Center/New York Presbyterian Hospital
New York 5128581, New York 5128638 10032
Contact:
Ken Watanabe
kw3145@cumc.columbia.edu

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Contact:
Bev Doyle
doyleb4@ccf.org

University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Robyn Broach, PhD
robyn.broach@pennmedicine.upenn.edu

More Details

NCT ID
NCT06456554
Status
Recruiting
Sponsor
RTI Surgical

Study Contact

Ana Villagomez
202-552-6013
avillagomez@mcra.com