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外阴癌前病变切除术中预防性使用抗生素:一项前瞻性随机对照试验。

Prophylactic antibiotics for excision of premalignant vulvar lesions: A pilot randomized controlled trial.

作者信息

Mullen Mary M, Grither Whitney R, Millimet Hannah, Mutch David G, Hagemann Andrea R, McCourt Carolyn K, Powell Matthew A, H Thaker Premal, Khabele Dineo, Kuroki Lindsay M

机构信息

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Washington University School of Medicine, and Alvin J. Siteman Cancer Center, St. Louis, MO, United States.

Department of Obstetrics and Gynecology, Washington University, St. Louis, MO, United States.

出版信息

Gynecol Oncol Rep. 2024 Aug 8;55:101476. doi: 10.1016/j.gore.2024.101476. eCollection 2024 Oct.

Abstract

No prospective data have been described to inform guidelines on antibiotic prophylaxis for partial vulvectomies. Thus, we conducted a single-center, pilot, double-blind randomized controlled trial to assess the effectiveness of prophylactic antibiotics to prevent wound complications after partial vulvectomies. Patients were randomly assigned 1:1 to preoperative antibiotics or no preoperative antibiotics. The primary outcome of 30-day postoperative wound complications occurred in 31 (62 %) of all patients, with no differences between groups. The most common wound complications were superficial separation (54.2 % antibiotic prophylaxis vs. 65.3 % no prophylaxis, p = 0.37) and surgical site infection (0 % antibiotic prophylaxis vs 7.7 % no prophylaxis, p = 0.49). However, this study was limited by differences in patient characteristics between the groups. This study provides data to perform power calculations for a trial examining the effect of preoperative antibiotics on surgical site infection.

摘要

目前尚无前瞻性数据可用于指导部分外阴切除术的抗生素预防指南。因此,我们开展了一项单中心、试点、双盲随机对照试验,以评估预防性使用抗生素预防部分外阴切除术后伤口并发症的有效性。患者按1:1随机分配接受术前抗生素治疗或不接受术前抗生素治疗。所有患者中有31例(62%)出现术后30天伤口并发症,两组之间无差异。最常见的伤口并发症是浅表分离(抗生素预防组为54.2%,未预防组为65.3%,p = 0.37)和手术部位感染(抗生素预防组为0%,未预防组为7.7%,p = 0.49)。然而,本研究受到两组患者特征差异的限制。本研究提供了数据,可用于进行一项试验的效能计算,该试验旨在研究术前使用抗生素对手术部位感染的影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9358/11369441/0e95bbcdb0b8/gr1.jpg

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