Actively Recruiting
Acellular Dermal Matrix Investigation in Breast Reconstruction
Led by RTI Surgical · Updated on 2026-04-30
467
Participants Needed
13
Research Sites
52 weeks
Total Duration
On this page
Sponsors
R
RTI Surgical
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating breast reconstruction techniques in females undergoing a two-stage procedure using a pre-pectoral method. This study compares breast reconstruction using an Acellular Dermal Matrix device called Cortiva Tissue Matrix with reconstruction performed without this matrix. The trial is non-randomized and aims to assess outcomes in women 22 years or older undergoing immediate breast reconstruction after mastectomy. Participants will be assigned to one of two groups breast reconstruction with the Cortiva Tissue Matrix device or reconstruction without the Acellular Dermal Matrix. Both groups will undergo a two-stage breast reconstruction using the pre-pectoral technique following nipple or skin-sparing mastectomy. The study is conducted across multiple centers and does not involve masking or blinding. During the study, participants will be monitored for major adverse events and health-related quality of life over 12 months. Additional assessments include changes in quality of life at one and two years, procedure-related and device-related adverse events at three months, one year, and two years, and histopathology evaluation during the second stage of the procedure. The trial lasts for up to two years, with ongoing safety and quality of life follow-ups.
CONDITIONS
Brief Title
Acellular Dermal Matrix Investigation in Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Genetic female
- Age 22 or older at time of consent
- Undergoing immediate breast reconstruction
- Two-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
You will not qualify if you...
- Planned concurrent reconstruction with pedicled flaps or free tissue
- Pregnant or breastfeeding
- Investigator has determined tissue is unsuitable for two-stage breast reconstruction
- History of psychological characteristics incompatible with surgery or prosthesis
- Serious or unstable medical conditions interfering with safety or compliance
- Vulnerable subject populations
- Currently in another clinical trial that conflicts with this study
- Prior neoadjuvant radiotherapy to reconstruction site or chest wall
- Active abscess or infection at reconstruction site
- Residual gross tumor at reconstruction site
- Active use of tobacco or nicotine products
- Body mass index over 35
- Uncontrolled diabetes with HbA1c of 7 or higher within 3 months prior to stage 1 procedure
- Currently taking systemic steroids or similar medications
Research Team
A
Ana Villagomez
P
Paul Bonvallet, PhD
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