Prospective Evaluation of Nanofibrillar Collagen Scaffold (BioBridge®) as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema
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 subject must be a breast cancer survivor, at least 3 years beyond completion of cancer therapy, free of clinical disease, and eligible for surgical intervention. Participants who are not able to safely undergo general anesthesia and/or perioperative care for VLNT are excluded.
• Ages 18 to 75 years (inclusive)
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
• Life expectancy \> 2 years
• Acquired (secondary) upper limb lymphedema secondary to breast cancer treatment
• The participant must be eligible for surgical intervention
• Swelling of 1 limb that is not completely reversed by elevation or compression
• Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
• Participants must have no evidence of disease (NED), have completed breast cancer therapy 3 years prior to enrollment; use of endocrine therapy is allowed.
• Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen
• Willingness to comply with recommended regimen of self care, with consistent use of compression garments from screening through the entire study duration (through the safety follow up visit), excluding the first 3 weeks postoperatively where patients are required to not wear compression. Self bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens are expected to remain consistent from screening though the entire study duration.
• Consistent use of an appropriately sized compression garment for daytime use.
• Limb volume (LV) in the affected limb and unaffected limb must be at least 10% of each other.
• Evidence of abnormal bioimpedance ratio, if feasible, based upon unilateral disease: L Dex \> 10 units.
• Willingness and ability to comply with all study procedures, including measurement of skin biopsy, and preoperative and postoperative imaging studies.
• Willingness and ability to understand, and to sign a written informed consent form document