Using an antibacterial matrix device for breast reconstruction
Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction With Infection Outcomes Assessment (ARIA)
NA · Melodi Health, Inc. · NCT06027996
This study is testing whether an antibacterial device can help improve recovery and reduce complications for patients getting breast reconstruction after a mastectomy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 702 (estimated) |
| Ages | 22 Years and up |
| Sex | Female |
| Sponsor | Melodi Health, Inc. (industry) |
| Locations | 10 sites (Palo Alto, California and 9 other locations) |
| Trial ID | NCT06027996 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of an absorbable antibacterial matrix device in patients undergoing two-stage prepectoral alloplastic breast reconstruction following mastectomy. It is a prospective, multicenter, randomized, controlled trial designed to compare outcomes between those receiving the matrix device and those who do not. The study aims to assess how this device may improve surgical outcomes and reduce complications in breast reconstruction procedures.
Who should consider this trial
Good fit: Ideal candidates are females aged 22 or older scheduled for unilateral or bilateral mastectomy with immediate reconstruction.
Not a fit: Patients with a history of neoadjuvant radiotherapy or those with active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and reduce infection rates in patients undergoing breast reconstruction.
How similar studies have performed: Other studies have shown promising results with similar antibacterial approaches in surgical settings, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female. * Age 22 or older at the time of enrollment. * Is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction. * Is able to and willing to comply with the study requirements and providing informed consent. Exclusion Criteria: * Has prior history of neoadjuvant radiotherapy. * Has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site. * Has an active abscess or infection requiring antibiotics anywhere in their body within 30 days. * Has a Body Mass Index (BMI) \< 14 or \> 40. * Is pregnant or is nursing; or plans to become pregnant during the course of the study. * Has any connective tissue/autoimmune disorder or rheumatoid disease. * Has known allergies to study device materials. * Is participating in another interventional research study that may interfere with study endpoints. * Has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that precludes participation. * Has a medical condition or is taking medications that would result in elevated risk and/or affect the validity of the study. * Intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomy skin flap thickness or viability) for immediate, two-stage post-mastectomy alloplastic prepectoral reconstruction in any breast.
Where this trial is running
Palo Alto, California and 9 other locations
- Stanford University — Palo Alto, California, United States (RECRUITING)
- University of Michigan Health — Ann Arbor, Michigan, United States (RECRUITING)
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
- Northwell Health — Staten Island, New York, United States (RECRUITING)
- The Ohio State University — Columbus, Ohio, United States (RECRUITING)
- UPMC — Pittsburgh, Pennsylvania, United States (RECRUITING)
- Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
- Monument Health — Rapid City, South Dakota, United States (RECRUITING)
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- University of Utah — Salt Lake City, Utah, United States (RECRUITING)
Study contacts
- Study coordinator: Michele Hilmer
- Email: michele.hilmer@melodihealth.com
- Phone: 210-279-0194
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.
Conditions: Breast Reconstruction