Recruiting

Breast Reconstruction

Sponsor:

RTI Surgical

Code:

NCT06456554

Conditions

Breast Reconstruction

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Accepted

Interventions

Acellular Dermal Matrix (Cortiva Tissue Matrix)

Study Details

Brief summary:

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

Conditions

Breast Reconstruction

Study ID

NCT06456554

Start date

Nov 22, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

467 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acellular Dermal Matrix

Breast reconstruction with Cortiva Tissue Matrix

no intervention: no Acellular Dermal Matrix

Breast reconstruction only with no ADM

Interventions

Acellular Dermal Matrix (Cortiva Tissue Matrix)

non-crosslinked dermis

Primary outcome measure

  • Rate of major adverse events [ Time Frame: 12 months ]
  • Health related quality of life [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Ana Villagomez

202-552-6013avillagomez@mcra.com

Paul Bonvallet, PhD

pbonvallet@evergenbio.com

Locations

University of Arkansas

Recruiting

Little Rock, Arkansas, United States, 72205

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Mamadou Seye

mamadou.seye@cuanschutz.edu

Principal Investigator:

Christodoulos Kaoutzanis, MD

University of Kansas

Recruiting

Lawrence, Kansas, United States, 66045

Contacts

Jessica Reynolds

619-753-2866jreynolds11@kumc.edu

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Aliyah Thomas

aliyaht@wustl.edu

Principal Investigator:

Trina Ebersole, MD

Mercy Hospital

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Brenna Reilly

Brenna.Reilly@mercy.net

Principal Investigator:

Michael Curtis, MD

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Brooke Miller

brooke.miller@nyulangone.org

Principal Investigator:

Nolan Karp, MD

New York Presbyterian Hospital/Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Ken Watanabe

kw3145@cumc.columbia.edu

Camila Boneu

cb4123@cumc.columbia.edu

Principal Investigator:

Christine Rohde, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Bev Doyle

doyleb4@ccf.org

Principal Investigator:

Risal Djohan, MD

Mercy

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Contacts

Maryann Martinovic, MD

(405) 749-7023maryann.martinovic@mercy.net

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Robyn Broach, PhD

robyn.broach@pennmedicine.upenn.edu

Principal Investigator:

Jessica Rose, DO

MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Sara Hull

713-500-2000SEHull@mdanderson.org

More Information

Sponsor

RTI Surgical

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by RTI Surgical on 2026-04-30.