Investigation of Acellular Dermal Matrix in Breast Reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a prospective, multi-center, dual-arm non-randomized study focusing on females undergoing a two-stage breast reconstruction using a pre-pectoral technique. Participants will receive an acellular dermal matrix treatment to evaluate its effectiveness in this surgical approach. The study aims to gather data on the outcomes of using Cortiva Tissue Matrix in breast reconstruction procedures. The trial will involve multiple locations to ensure a diverse participant pool.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Arkansas
  Little Rock, Arkansas, United States Recruiting
• City of Hope National Medical Center
  Duarte, California, United States Recruiting
• University of Colorado
  Aurora, Colorado, United States Recruiting
• University of Kansas
  Lawrence, Kansas, United States Recruiting
• Washington University
  St Louis, Missouri, United States Recruiting
• Mercy Hospital
  St Louis, Missouri, United States Recruiting

Study contacts

• Study coordinator: Ana Villagomez
• Email: avillagomez@mcra.com
• Phone: 202-552-6013

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.