Department of Surgery, Zuyderland Medical Center, Postbus 5500, 6130 MB, Sittard, The Netherlands.
Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands.
Sci Rep. 2021 May 5;11(1):9620. doi: 10.1038/s41598-021-89036-3.
Patients and breast cancer surgeons are frequently confronted with wound complications after mastectomy. Negative pressure wound therapy (NPWT) is a promising technique for preventing wound complications after skin closure in elective surgery. However, a clinical study evaluating postoperative complications following the use of NPWT, focusing solely on closed incisions in patients undergoing mastectomy, has yet to be performed. Between June 2019 and February 2020, 50 consecutive patients underwent mastectomy with NPWT during the first seven postoperative days. This group was compared to a cohort of patients taking part in a randomized controlled trial between June 2014 and July 2018. Primary outcome was the rate of postoperative wound complications, i.e. surgical site infections, wound necrosis or wound dehiscence during the first three postoperative months. Secondary outcomes were the number of patients requiring unplanned visits to the hospital and developing clinically significant seroma (CSS). In total, 161 patients were analyzed, of whom 111 patients in the control group (CON) and 50 patients in the NPWT group (NPWT). Twenty-eight percent of the patients in the NPWT group developed postoperative wound complications, compared to 18.9% in the control group (OR = 1.67 (95% CI 0.77-3.63), p = 0.199). The number of patients requiring unplanned visits or developing CSS was not statistically significant between the groups. This study suggests that Avelle negative pressure wound therapy in mastectomy wounds does not lead to fewer postoperative wound complications. Additionally, it does not lead to fewer patients requiring unplanned visits or fewer patients developing clinically significant seromas.Trial registration: ClinicalTrials.gov number, NCT03942575. Date of registration: 08/05/2019.
患者和乳腺癌外科医生经常在乳房切除术后面临伤口并发症。负压伤口治疗（NPWT）是一种有前途的技术，可用于预防择期手术皮肤闭合后的伤口并发症。然而，尚未进行专门针对接受乳房切除术的患者的闭合切口的使用 NPWT 后的术后并发症的临床研究。2019 年 6 月至 2020 年 2 月期间，50 例连续患者在术后的前 7 天内接受了 NPWT 乳房切除术。该组与 2014 年 6 月至 2018 年 7 月期间参加随机对照试验的患者队列进行了比较。主要结果是术后伤口并发症（即前 3 个月内的手术部位感染、伤口坏死或伤口裂开）的发生率。次要结果是需要计划外就诊的患者人数和发生临床显著血清肿（CSS）的患者人数。共分析了 161 例患者，其中对照组（CON）111 例，NPWT 组（NPWT）50 例。NPWT 组中 28%的患者发生术后伤口并发症，对照组为 18.9%（OR=1.67（95%CI 0.77-3.63），p=0.199）。两组之间需要计划外就诊或发生 CSS 的患者人数无统计学差异。这项研究表明，Avelle 负压伤口治疗在乳房切除术伤口中不会导致术后伤口并发症减少。此外，它不会导致需要计划外就诊的患者减少或发生临床显著血清肿的患者减少。试验注册：ClinicalTrials.gov 编号，NCT03942575。注册日期：2019 年 8 月 5 日。
