Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique
Females at least 22 years of age
Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction
Willing to provide Informed Consent
Able to return for all required study visits
Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure
Has a residual gross tumor at the intended reconstruction site
Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy
Has undergone previous radiation therapy to the reconstruction site or chest wall, or is scheduled to undergo post-operative radiation therapy at the reconstruction site
Single group
FlexHD® Pliable
DeviceAcellular Dermal Matrix
No intervention
Other interventionHistorical Control Arm
Frequency of major complication
Complications that require additional hospitalization or reoperation
Frequency of reconstructive failure
Removal/explantation of the breast implant
Change in patient reported outcomes
Change from baseline in patient reported outcomes as measured by the BREAST-Q (Scoring 0-100; 0=less satisfaction; 100= greater satisfaction)
Pain
Pain scores as measured by the Numerical Pain Rating Scale (NPRS) (Scoring 0-10; 0=no pain; 10= worst imaginable pain)
Adverse events
Reported adverse events
Click on the lead sponsor to view all of their trials.
Musculoskeletal Transplant Foundation
Lead sponsor
MCRA (an IQVIA business)
Collaborator
Bruder Consulting International, LLC
Collaborator
