注射用杆菌肽召回：对即刻乳房植入手术结局的影响。
Bacitracin for Injection Recall: Impact on Immediate Breast Implant Surgical Outcomes.
机构信息
Division of Plastic and Reconstructive Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Department of Plastic and Reconstructive Surgery, MedStar Georgetown University Hospital, Washington, District of Columbia, USA.
出版信息
Breast J. 2022 Aug 31;2022:1389539. doi: 10.1155/2022/1389539. eCollection 2022.
BACKGROUND
Triple-antibiotic irrigation of breast implant pockets is a mainstay of infection prophylaxis in breast reconstruction and augmentation. The recall of bacitracin for injection due to risk of anaphylaxis and nephrotoxicity in January 2020, a staple component of the irrigation solution, has raised concern for worsened postoperative sequelae. This study aimed to investigate pre- and post-recall implant-based breast surgery to analyze the impact of bacitracin in irrigation solutions on infection rates.
METHODS
All implant-based breast reconstruction or augmentation surgeries from January 2019 to February 2021 were retrospectively reviewed. In a regression discontinuity study design, patients were divided into pre- and post-recall groups. Patient demographics, surgical details, and outcomes including infection rates were collected. Differences in complication rates were compared between groups and with surgical and patient factors.
RESULTS
254 implants in 143 patients met inclusion criteria for this study, with 172 implants placed before recall and 82 placed after recall. Patients in each cohort did not differ in age, BMI, smoking status, or history of breast radiation or capsular contracture ( > 0.05). All breast pockets were irrigated with antibiotic solution, most commonly bacitracin, cefazolin, gentamycin, and povidone-iodine before recall (116,67.4%) and cefazolin, gentamycin, and povidone-iodine after recall (59,72.0%). There was no difference in incidence of infection (6.4% vs. 8.5%, =0.551) or cellulitis (3.5% vs. 3.7%, =0.959) before and after recall. Implant infection was associated with smoking history ( < 0.001) and increased surgical time (=0.003).
CONCLUSIONS
Despite the recent recall of bacitracin from inclusion in breast pocket irrigation solutions, our study demonstrated no detrimental impact on immediate complication rates. This shift in irrigation protocols calls for additional investigations into optimizing antibiotic combinations in solution, as bacitracin is no longer a viable option, to improve surgical outcomes and long-term benefits.
背景
在乳房重建和隆胸中，三抗生素冲洗乳房植入袋是感染预防的主要手段。由于注射用杆菌肽由于过敏反应和肾毒性的风险，在 2020 年 1 月被召回，这是冲洗液的主要成分，这引发了对术后后遗症恶化的担忧。本研究旨在调查召回前和召回后基于植入物的乳房手术，以分析冲洗液中杆菌肽对感染率的影响。
方法
回顾性分析 2019 年 1 月至 2021 年 2 月期间所有基于植入物的乳房重建或隆胸手术。在回归不连续性研究设计中，患者分为召回前和召回后组。收集患者人口统计学、手术细节和结果，包括感染率。比较两组之间以及与手术和患者因素相关的并发症发生率差异。
结果
本研究纳入了 143 名患者的 254 个植入物，其中 172 个植入物在召回前放置，82 个植入物在召回后放置。每个队列的患者在年龄、BMI、吸烟状况或乳房放疗或包膜挛缩史方面无差异（>0.05）。所有乳房袋均用抗生素溶液冲洗，召回前最常用杆菌肽、头孢唑林、庆大霉素和聚维酮碘（116，67.4%），召回后最常用头孢唑林、庆大霉素和聚维酮碘（59，72.0%）。召回前后感染发生率（6.4%与 8.5%，=0.551）和蜂窝织炎发生率（3.5%与 3.7%，=0.959）无差异。植入物感染与吸烟史有关（<0.001），且与手术时间延长有关（=0.003）。
结论
尽管杆菌肽最近已从乳房口袋冲洗液中召回，但我们的研究表明，这对即刻并发症发生率没有不利影响。冲洗方案的这种转变需要进一步研究，以优化溶液中的抗生素组合，因为杆菌肽不再是可行的选择，以改善手术结果和长期获益。
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