LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)

The proposed study utilizes Fibralign's BioBridge® Collagen Matrix (BioBridge), a sterile implantable biocompatible and biodegradable surgical mesh ribbon comprised of highly purified porcine collagen. The Class II device was cleared by CDRH Division of Surgical Devices on 8 January 2016 under 510(k) K151083. The device will be used for soft tissue surgical support at the time of vascularized lymph node transplant surgery (VLNT); the device will be used, specifically, for surgical support of the lymphatic component of the soft tissue. Primary endpoint is the post surgical % change in excess limb volume, measured at 12 months following the surgical procedure. Secondary endpoints are change in quality of life scores measured by LLIS and change in lymphatic function as measured by indocyanine green (ICG) fluorescence imaging.