Safety And Effectiveness Of FlexHD® Pliable Acellular Dermal Matrix In Implant-Based Breast Reconstruction

Musculoskeletal Transplant Foundation

Summary

Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique

Eligibility

Age range: 22+ years
Sex: Female
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * 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 * Must read and understand English language Exclusion Criteria: * 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 implantat…

Interventions

Device
FlexHD® Pliable
Acellular Dermal Matrix
Other
No intervention
Historical Control Arm

Location

Jonathan Heistein, MD Plastic & Reconstructive Surgery
Fort Worth, Texas
(817) 820-0000

Safety And Effectiveness Of FlexHD® Pliable Acellular Dermal Matrix In Implant-Based Breast Reconstruction

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions