NCT06456554 · RTI Surgical
Acellular Dermal Matrix Investigation in Breast Reconstruction
(ADMIRE)
What this study is about
forward-looking, multi-center, dual-treatment group$1 non-randomly assigned clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
View original scientific description
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Little Rock, Arkansas
- Duarte, California
- Aurora, Colorado
- Lawrence, Kansas
- St Louis, Missouri
- New York, New York
- Cleveland, Ohio
- Oklahoma City, Oklahoma
- Philadelphia, Pennsylvania
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 30, 2026 · Source of record for eligibility and locations