NCT06027996RecruitingNot Applicable
Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction With Infection Outcomes Assessment (ARIA)
Melodi Health, Inc.20 sites in 1 country702 target enrollmentStarted: August 9, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 702
- Locations
- 20
- Primary Endpoint
- Complications of Breast Reconstruction
Study Overview
Brief Summary
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 >
- •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.
Outcomes
Primary Outcomes
Complications of Breast Reconstruction
Time Frame: 6 months
Key local complications
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (20)
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