Melodi Matrix™ in Breast Reconstruction
ConditionBreast Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22+
SponsorMelodi Health, Inc.
About this trial
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Absorbable Antibacterial Matrix
DeviceSoft tissue support coated with antibiotics
Treatment groups
702 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Complications of Breast Reconstruction
Key local complications
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov