Department of Surgical Oncology, Canisius Wilhelmina Hospital, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands.
Department of Surgical Oncology, Diakonessenhuis, Bosboomstraat 1, 3582 KE, Utrecht, The Netherlands.
BMC Cancer. 2023 Jul 17;23(1):667. doi: 10.1186/s12885-023-11154-0.
Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. The quilting suture technique, in which the skin flaps are sutured to the pectoralis muscle, leads to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. However, implementation is lagging due to unknown side effects, increase in operation time and cost effectiveness. Main objective of this study is to assess the impact of large scale implementation of the quilting suture technique in patients undergoing mastectomy and/or axillary lymph node dissection (ALND).
The QUILT study is a stepped wedge design study performed among nine teaching hospitals in the Netherlands. The study consists of nine steps, with each step one hospital will implement the quilting suture technique. Allocation of the order of implementation will be randomization-based. Primary outcome is 'textbook outcome', i.e.no wound complications, no re-admission, re-operation or unscheduled visit to the outpatient clinic and no increased use of postoperative analgesics. A total of 113 patients is required based on a sample size calculation. Secondary outcomes are shoulder function, cosmetic outcome, satisfaction with thoracic wall and health care consumption. Follow-up lasts for 6 months.
This will be one of the first multicentre prospective studies in which quilting without postoperative wound drain is compared with conventional wound closure. We hypothesize that quilting is a simple technique to increase textbook outcome, enhance patient comfort and reduce health care consumption.
血清肿是乳腺癌手术后最常见的并发症，报道的发病率高达 90%。血清肿会引起患者不适，与手术部位感染（SSI）有关，常需要治疗，并增加医疗保健的消耗。缝合皮瓣与胸大肌的缝扎技术可显著减少血清肿，减少抽吸次数和手术部位感染。然而，由于未知的副作用、手术时间增加和成本效益，该技术的实施较为滞后。本研究的主要目的是评估在接受乳房切除术和/或腋窝淋巴结清扫术（ALND）的患者中广泛实施缝扎技术的影响。
QUILT 研究是在荷兰的九所教学医院中进行的一项逐步楔形设计研究。该研究由九个步骤组成，每个步骤一所医院将实施缝扎技术。实施顺序的分配将基于随机化。主要结果是“教科书结果”，即无伤口并发症、无再入院、再手术或门诊预约、无术后止痛药使用增加。根据样本量计算，共需要 113 例患者。次要结果是肩部功能、美容结果、胸壁满意度和医疗保健消耗。随访持续 6 个月。
这将是首次将无术后引流的缝扎与常规伤口闭合进行比较的多中心前瞻性研究之一。我们假设缝扎是一种简单的技术，可以提高教科书结果，增强患者舒适度并减少医疗保健消耗。
