Reduction of lymphocele rate in patients undergoing sentinel node biopsy for melanoma by intraoperative placement of plant-based hemostatic powder: Results of a prospective trial

Background: Lymphocele is a complication of sentinel node biopsy (SNB) for melanoma. Plant-based hemostatic powder (PBHP) may have a lymphostatic benefit. We studied whether PBHP placed intraoperatively could reduce lymphocele rates. Methods: We performed an open label, prospective, IRB -approved, before- and-after, matched control trial of PBHP placed into the wound in patients undergoing SNB of groin or axillary nodes for melanoma staging. Patient/tumor features and lymphocele rates were compared by standard statistical tests. Results: 66 control and 66 treatment (49 axillary and 17 groin in each arm) SNBs were performed in 61 and 55 patients, respectively, for a total 132 SNBs in 116 patients. Patient and tumor features were similar between groups. Nineteen lymphoceles occurred (14.4%); lymphocele rates were 22.2% (14/66) in the control group and 7.6% (5/66) in the treatment group (p = 0.026). The reduction in lymphocele rates between arms was greater for axillary than for groin sites (87.5% vs. 33%); the axillary reduction was statistically significant (p = 0.030). Conclusions: Intra-operative placement of PBHP reduced the rate of lymphoceles in patients undergoing SNB for melanoma.