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 study will investigate whether addition of the BioBridge Collagen Matrix to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper extremity. This clinical study will also be used in support of IDE G200200 review conducted by the FDA. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
Micro-surgical procedure for vascularized lymph node transfer (VLNT)
Stanford University
Stanford, California, United States
RECRUITINGExcess limb volume change
Change in % of (excess) limb volume in the intervention group relative to control group
Time frame: Baseline and 12 months after treatment
LLIS survey
Lymphedema-specific instrument to measure impairments, activity limitations, and participation restrictions in those living with any extremity lymphedema
Time frame: Baseline and 12 months after treatment
L-Dex bioimpedance spectroscopy.
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.
Time frame: Baseline and 12 months after treatment
Histology
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.
Time frame: Baseline and 12 months after treatment
ICG fluorescence imaging
Change in lymphatic function assessed by ICG fluorescence imaging
Time frame: Baseline and 12 months after treatment
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