Investigation of Acellular Dermal Matrix in Breast Reconstruction
Acellular Dermal Matrix Investigation in Breast Reconstruction
This study is testing if using a special tissue matrix can improve results for women having breast reconstruction surgery with a new technique.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 467 (estimated) |
| Ages | 22 Years and up |
| Sex | Female |
| Sponsor | RTI Surgical Industry-sponsored |
| Locations | 13 sites (Little Rock, Arkansas and 12 other locations) |
| Trial ID | NCT06456554 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are genetic females aged 22 or older who are undergoing immediate breast reconstruction with a two-stage pre-pectoral technique.
Not a fit: Patients who are pregnant, breastfeeding, or have serious pre-existing medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and recovery for women undergoing breast reconstruction.
How similar studies have performed: Other studies have explored the use of acellular dermal matrices in breast reconstruction, showing promising results, but this specific approach may offer novel insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Rock, Arkansas and 12 other locations
- 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)
- NYU Langone Health — New York, New York, United States (Recruiting)
- New York Presbyterian Hospital/Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Mercy Hospital — Oklahoma City, Oklahoma, United States (Not_yet_recruiting)
- Mercy — Oklahoma City, Oklahoma, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- MD Anderson — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Ana Villagomez
- Email: avillagomez@mcra.com
- Phone: 202-552-6013
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.