Melodi Matrix™ in Breast Reconstruction

Launched by MELODI HEALTH, INC. · Sep 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called Melodi Matrix™ to help women who are undergoing breast reconstruction after a mastectomy. The trial aims to find out if this absorbable antibacterial matrix device is safe and effective when used during a two-stage breast reconstruction procedure. This means that the device could potentially help improve the recovery process and outcomes for women getting breast implants.

To participate in the trial, women need to be at least 22 years old and scheduled for a mastectomy with immediate breast reconstruction. However, some women may not be eligible, such as those who have had certain previous treatments or conditions that could complicate surgery. If eligible, participants will be asked to follow specific study requirements and provide their consent to join. Throughout the trial, participants can expect close monitoring and support as they go through the reconstruction process, helping researchers gather important information about the device's use.

Gender

FEMALE

Eligibility 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.