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Lymphatic Diseases

Vascularized Lymph Node Transplant surgery (VLNT) supplemented by BioBridge Collagen Matrix implantation

Vascularized Lymph Node Transplant surgery (VLNT) only

BioBridge Collagen Matrix (BioBridge) is a sterile implantable bio-compatible 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.

BioBridge® Collagen Matrix

Micro-surgical procedure for vascularized lymph node transfer (VLNT)

Vascularized Lymph Node Transfer (VLNT)

Scully Hsu

Janine Grohar

Edward I Chang, MD

David W Chang, MD, FACS

Rebecca Garza, MD

To investigate whether the addition of Fibralign's BioBridge® Collagen Matrix (BioBridge) devices to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm.

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.

Partially Blinded: Patients will be informed which group they are randomized into and given the option to opt out of the study. Investigators (other than surgeons conducting surgery) and study personnel involved in patient measurements will be unaware of the patient treatment option.

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

LymphBridge: Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema

Change in % of (excess) limb volume in the intervention group relative to control group

Lymphedema-specific instrument to measure impairments, activity limitations, and participation restrictions in those living with any extremity lymphedema

Change in the Lymphedema Index (L-Dex) in the intervention group relative to control group. The L-Dex score has the requisite sensitivity and specificity to detect the differences in retained interstitial fluid that might discriminate the therapeutic responses of the treated patients. It has been established that the normal range of the L-Dex score is in the interval from -10 to +10 units; the higher score the more difference is in the retained interstitial fluid between the affected and unaffected limbs.

Change in cutaneous histological architecture. The impact of treatment on the cutaneous histopathology will be evaluated through the use of an empirically derived scoring system and will be performed by a dermatopathologist.

Change in lymphatic function assessed by ICG fluorescence imaging

Spots Global Cancer Trial Database for vascularized lymph node transfer (vlnt)