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Purpose

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

Condition

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.