Spiekerman van Weezelenburg Merel A, de Rooij Lisa, Aldenhoven Loeki, Broos Pieter P H L, van Kuijk Sander M J, van Haaren Elisabeth R M, Janssen Alfred, Vissers Yvonne L J, Beets Geerard L, van Bastelaar James
Department of Surgery, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands.
Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, The Netherlands.
Breast Care (Basel). 2022 Dec;17(6):567-572. doi: 10.1159/000525839. Epub 2022 Jul 4.
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.
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.
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.
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.
腋窝淋巴结清扫术（ALND）用于治疗乳腺癌和黑色素瘤患者的局部区域转移性疾病。然而，其并发症却声名狼藉，最常见的是血清肿形成及其后遗症。已经开展了大量研究来评估ALND术后血清肿的形成；然而，这些结果尚无定论。因此，本前瞻性研究旨在评估一种现成的止血贴片Hemopatch®，以评估其对ALND术后血清肿形成的影响。
在本前瞻性研究中，将20例ALND术后接受Hemopatch®治疗的患者的前瞻性队列与2014年至2019年间接受ALND治疗的患者的回顾性队列进行比较。主要结局指标是ALND术后发生具有临床意义的血清肿（CSS）的患者数量。此外，还评估了伤口并发症的数量、后续干预措施、额外的门诊就诊次数和引流量。如果两组之间的比例差异>50%，则认为两组之间的差异具有临床相关性。
总共纳入了20例前瞻性患者和42例回顾性患者。在Hemopatch®组中，30%的患者发生了CSS，而对照组为43%。两组均有3例患者发生手术部位感染。Hemopatch®组中35%的患者需要额外的非计划就诊，而对照组为62%。
ALND术后应用Hemopatch®并未导致CSS和伤口并发症在临床上有意义的减少。然而，使用Hemopatch®的患者需要额外门诊就诊的次数较少。由于参与者数量有限，Hemopatch®在ALND中的真正价值仍不清楚。
