Breast Reconstruction
Conditions
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.
Interventions
DEVICEAbsorbable Antibacterial Matrix
Soft tissue support coated with antibiotics
Sponsors
Melodi Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications of Breast Reconstruction | 6 months | Key local complications |
Countries
United States
Contacts
Primary ContactMichele Hilmer
Outcome results
None listed