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临床试验/NCT04818931
NCT04818931已完成不适用

Does a Preoperative Prophylactic Antibiotic Reduce Surgical Site Infection Following Wire-localized Lumpectomy

CHU de Quebec-Universite Laval1 个研究点 分布在 1 个国家目标入组 326 人开始时间: 2018年4月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
326
试验地点
1
主要终点
Number of participants with surgical site infection in each group

研究概览

简要总结

Background: Data on the benefits of preoperative prophylactic antibiotics for breast surgery are conflicting and there is no guideline for their use for wire-localized lumpectomy. The aims of this study were to determine whether a single dose of pre-operative antibiotic reduces surgical site infection (SSI) for wire-localized lumpectomy and to identify risk factors for SSI.

Methods: This was a prospective randomized trial carried out from April 2018 to June 2019 at the "Centre des Maladies du Sein du CHU de Québec - Université Laval", a tertiary center specialized in breast surgery. After informed consent, patients who underwent wire-localized lumpectomy were randomized to receive or not a pre-operative single dose of prophylactic antibiotic (cefazolin 2 g or clindamycin 900 mg in case of penicillin allergy). Data regarding demographics, comorbidities, perioperative details, and SSI were analyzed. SSI was considered if: 1) patient had positive wound cultures; or 2) required abscess drainage; or 3) received antibiotic treatment for breast symptoms (e.g., swelling, erythema, congestion) within 30 days after operation, in the absence of wound culture or in the presence of negative results. The patients and the investigator responsible for data collection were blind to grouping. All patients were called 30 days after surgery to be sure that they did not consult at another hospital for surgical wound infection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • >18 years of age
  • scheduled for a wire-localized lumpectomy

排除标准

  • pregnant or breastfeeding women
  • incapacity to give informed consent
  • preoperative breast infection
  • patients known to be colonized with MRSA
  • immunocompromised patients
  • preoperative antibiotic prophylaxis needed for any concomitant condition.

研究组 & 干预措施

Antibiotics

Experimental

Cefazolin 2 g or clindamycin 900 mg in case of penicillin allergy

干预措施: Cefazolin Injection (Drug)

结局指标

主要结局

Number of participants with surgical site infection in each group

时间窗: within 30 days after operation

1) patient had positive wound cultures; or 2) required abscess drainage; or 3) received antibiotic treatment for breast symptoms (e.g., swelling, erythema, congestion)

次要结局

未报告次要终点

研究者

发起方
CHU de Quebec-Universite Laval
申办方类型
Other
责任方
Sponsor

研究点 (1)

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