A Randomized Clinical Trial of the LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

Inclusion Criteria: * Ages 18 to 75 years (inclusive) * Patients undergoing unilateral or bilateral breast cancer related axillary lymphadenectomy * Free of distant metastasis in preoperative screening * Histology results of axillary lymph nodes could be either Negative or Positive * Patients who undergo preoperative chemotherapy can be included * Willingness and ability to provide written informed consent * Willingness and ability to comply with all study procedures Exclusion Criteria: * Primary lymphedema of the affected upper limb * Secondary lymphedema of the affected limb prior to the lymphadenectomy * Radiotherapy at the axilla before the study / surgery * Allergic reaction to porcine collagen or ICG * Receiving radiation therapy to the involved nodal basin in a period less than 4 weeks after the surgery * Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening * Other medical condition that could lead to limb edema, such as (but not limited to primary lymphedema or acute venous thrombosis * Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (e.g., pain, swelling, decreased range of motion) * Either of the following, at the time of baseline evaluation: ipsilateral:contralateral limb volume ratio\>1.1 or R0 bioimpedance ratio \> 1.106 when the nondominant limb is at risk, and 1.134 when the dominant limb is at risk. * Life expectancy \< 2 years for any reason * Pregnancy or nursing * Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening * Severe psychiatric disease * Significant or chronic renal insufficiency (defined as serum creatinine \> 2.5 mg/dL or an estimated glomerular filtration rate \[eGFR\] \< 30 mL/min at screening) or requires dialytic support * Hepatic dysfunction, defined as alanine transaminase (ALT) or aspartate transaminase (AST) levels \> 3 × upper limit of the normal range (ULN) and/or bilirubin level \> 2 × ULN at screening * Absolute neutrophil count \< 1500 mm3 at screening * Hemoglobin concentration \< 9 g/dL at screening * Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study