Evaluating HEmopatch® in Reducing Seroma-Related Complications following Axillary Lymph Node DIssection: A Pilot Study (HEIDI).

Purpose: Axillary lymph node dissection (ALND) is performed to treat locoregional metastatic disease in breast cancer and melanoma patients. However, it is notorious for its complications, most commonly seroma formation and its sequelae. Ample research has been done to evaluate seroma formation after ALND; these results, however, have not been conclusive. Hence, this pilot study aimed to evaluate a readily available haemostatic patch, Hemopatch®, to assess its effect on seroma formation following ALND.

Methods: In this pilot study, a prospective cohort of 20 patients receiving Hemopatch® following ALND was compared to a retrospective cohort of patients who underwent ALND between 2014 and 2019. The primary outcome measure was the number of patients developing clinically significant seroma (CSS) after ALND. Additionally, the number of wound complications, subsequent interventions, additional outpatient clinic visits, and drain output was assessed. Differences between groups were deemed clinically relevant if the proportions differed >50% between groups.

Results: In total, 20 prospective and 42 retrospective patients were included. In the Hemopatch® group, 30% of the patients developed CSS, compared to 43% in the control group. Three patients in both groups developed a surgical site infection. Thirty-five percent of patients in the Hemopatch® group required additional unscheduled visits versus 62% of patients in the control group.

Conclusion: The application of Hemopatch® after ALND did not lead to a clinically relevant reduction of CSS and wound complications. However, fewer Hemopatch® patients required additional outpatient clinic visits. Due to the limited amount of participants, the true value of Hemopatch® in ALND remains unclear.