Infection Outcomes Assessment of Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-010622
NCT ID: NCT06027996
Sponsor Protocol Number: ARIA TRIAL
About this study
The purpose of this study is to demonstrate the safety and effectiveness of the Melodi Absorbable Antibacterial Matrix for soft tissue support in immediate, two-stage postmastectomy alloplastic prepectoral breast reconstruction, to support an FDA Premarket Approval (PMA) Application.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 02/18/2025. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Aparna Vijayasekaran, M.B.B.S. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available