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Acellular Dermal Matrix Investigation in Breast Reconstruction

RTI Surgical · with MCRA · NCT06456554

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
467
US sites recruiting
12
Study start
November 22, 2024
Record last updated
April 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Acellular Dermal Matrix (Cortiva Tissue Matrix)

Conditions: Breast Reconstruction

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • University of Arkansas

    Little Rock, AR 72205

  • City of Hope National Medical Center

    Duarte, CA 91010

    Site contact: Shalini Shah

  • University of Colorado

    Aurora, CO 80045

    Site contact: Mamadou Seye · mamadou.seye@cuanschutz.edu

  • University of Kansas

    Lawrence, KS 66045

    Site contact: Jessica Reynolds · 619-753-2866 · jreynolds11@kumc.edu

  • Washington University

    St Louis, MO 63110

    Site contact: Aliyah Thomas · aliyaht@wustl.edu

  • Mercy Hospital

    St Louis, MO 63141

    Site contact: Brenna Reilly · Brenna.Reilly@mercy.net

  • NYU Langone Health

    New York, NY 10016

    Site contact: Brooke Miller · brooke.miller@nyulangone.org

  • New York Presbyterian Hospital/Columbia University Irving Medical Center

    New York, NY 10032

    Site contact: Ken Watanabe · kw3145@cumc.columbia.edu

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Bev Doyle · doyleb4@ccf.org

  • Mercy

    Oklahoma City, OK 73120

    Site contact: Maryann Martinovic, MD · (405) 749-7023 · maryann.martinovic@mercy.net

  • University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Robyn Broach, PhD · robyn.broach@pennmedicine.upenn.edu

  • MD Anderson

    Houston, TX 77030

    Site contact: Sara Hull · 713-500-2000 · SEHull@mdanderson.org

Study contacts (from the official record)

  • Ana Villagomez · 202-552-6013 · avillagomez@mcra.com
  • Paul Bonvallet, PhD · pbonvallet@evergenbio.com
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Acellular Dermal Matrix Investigation in Breast Reconstruction (NCT06456554) | Bored Studies