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