Antibiotic prophylaxis in thyroid surgery: a preliminary multicentric Italian experience.

Nicola Avenia, Alessandro Sanguinetti, Roberto Cirocchi, Giovanni Docimo, Mark Ragusa, Roberto Ruggiero, Eugenio Procaccini, Carlo Boselli, Fabio D'Ajello, Francesco Barberini, Domenico Parmeggiani, Lodovico Rosato, Francesco Sciannameo, Giorgio De Toma, Giuseppe Noya
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Abstract

Post-operatory wound infections are a very uncommon finding after thyroidectomy. For these reasons international guidelines do not routinely recommend systemic antibiotic prophylaxis. The benefits of this antibiotic prophylaxis is not supported by clinical evidence in the literature. We have conducted a multicentric randomized double-blind trial on 500 patients who had undergone thyroidectomy for goitre or thyroid carcinoma. The 500 patients enrolled in the study (mean age 47 years) were randomized in two subgroups of 250 patients. 250 patients were treated with standard antibiotic prophylaxis with sulbactam/ampicillin 1 fl (3 gr.) 30 min before surgery. No antibiotic prophylaxis was instituted in the remainder 250 patients. Our RCT showed that prophylactic antibiotic treatment is not beneficial in patients younger than eighty years old, with no concomitant metabolic, infective and hematologic disease, with no cardiac valvulopathies, not under steroidal or immunosuppressive treatment, and not severely obese. Our study should be regarded only as a preliminary RCT, and should be followed by a study in which a larger number of patients should be enrolled so that statistically significant data can be obtained.

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甲状腺手术中的抗生素预防:意大利多中心初步经验。
甲状腺切除术后伤口感染并不常见。因此,国际指南并不建议常规使用全身性抗生素进行预防。这种抗生素预防性治疗的益处并没有得到文献中临床证据的支持。我们对500名因甲状腺肿或甲状腺癌而接受甲状腺切除术的患者进行了一项多中心随机双盲试验。参加研究的500名患者(平均年龄47岁)被随机分为两组,每组250人。250名患者在手术前30分钟接受舒巴坦/氨苄西林1 fl(3克)的标准抗生素预防治疗。其余 250 名患者未使用抗生素预防。我们的研究表明,对于年龄小于 80 岁,没有合并代谢、感染和血液疾病,没有心脏瓣膜病,没有接受类固醇或免疫抑制治疗,没有严重肥胖的患者,预防性抗生素治疗并无益处。我们的研究只能被视为一项初步的 RCT 研究,随后还应该进行一项研究,招募更多的患者,以便获得具有统计学意义的数据。
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