Abstract
BACKGROUND: The aim of this study was to compare the clinical outcomes between breast cancer patients who underwent axillary lymph node dissection with postoperative management using a polyethylene glycol-coated patch versus axillary drainage. The direct costs associated with both postoperative management strategies were also evaluated. METHODS: This was a multicentre RCT in women with breast cancer who underwent axillary lymph node dissection (ClinicalTrials.gov identifier: NCT04487561). Patients were randomly assigned (1 : 1) to receive either drainage or a polyethylene glycol-coated patch as postoperative management. The primary endpoints were the need for an emergency department visit for any event related to the surgery and the rate of seroma development. RESULTS: A total of 227 patients were included , 115 in the patch group (50.7 per cent) and 112 (29.4 per cent ) in the drainage group. The incidence of emergency department visits was significantly greater for patients with drainage versus a polyethylene glycol-coated patch (incidence rate difference 26.1 per cent, 95 per cent c.i. 14.5 to 37.7 per cent; P < 0.001). Conversely, the seroma rate was significantly higher in the polyethylene glycol-coated patch group (incidence rate difference 22.8 per cent, 95 per cent c.i. 6.7 to 38.9 per cent; P < 0.0055). Compared with drainage, using a polyethylene glycol-coated patch resulted in cost savings of €100.41 per patient. An incremental cost-effectiveness ratio analysis found that drainage was associated with an incremental cost-effectiveness ratio of €7594.4 for no need for hospital admission and €491.7 for no need for an emergency department visit. CONCLUSION: Compared with patients who received drainage after axillary lymph node dissection, the use of a polyethylene glycol-coated patch resulted in a higher rate of seroma, but a lower number of postoperative outpatient or emergency department visits and thus a reduction in overall costs.