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临床试验/NCT01980082
NCT01980082已完成4 期

Antibiotic Prophylaxis for Revision, Clean Head and Neck Surgery

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
53
试验地点
1
主要终点
Surgical wound infection, sepsis, bacteremia.

研究概览

简要总结

We hypothesized that revision clean head & neck surgery may have a higher rate of wound infection that may be lowered with prophylactic antibiotic treatment.

详细描述

Surgical wound infection (SWI) is a common complication in many operations, including head and neck (H&N) surgery, with reported rates ranging between 3.5 to 87%. While prophylactic antibiotic use has been shown to decrease SWI in clean-contaminated and contaminated surgery, its use in clean surgery is debatable. In most types of clean surgery the value of prophylactic antibiotics is minimal, however in some cases it might be justified, including in radical neck dissections, in a previously irradiated neck, those with a tracheostomy and immunosuppressed patients - although there is no consensus regarding these risk factors.

Previous research has shown that adherence to guidelines regarding prophylactic antibiotic use is lacking, with one study showing a greater than 40% rate of inappropriate antibiotic administration. This may be partially attributed to some patients having other risk factors, not covered by existing guidelines.

One such risk factor is previous H&N surgery. While there are no studies addressing this issue in H&N surgeries, a study in clean neurosurgical operations has shown an almost trice-fold increase in SWI rates in some operations (4% vs. 13%).

The purpose of this study is to investigate the effect of prophylactic antibiotic use in repeat clean H&N surgery.

This is a double-blind, randomized, placebo-controlled study. The study will be conducted at the Otolaryngology department in Rabin Medical Center, Petah Tikva.

研究设计

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

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Previous H&N surgery.
  • Planned second H&N clean surgery (the definition of a second H&N surgery is a surgery which will include the same skin incision as the previous operation).

排除标准

  • Previous neck irradiation.
  • Tracheostomy status.
  • Immunosuppression.
  • Concurrent infection which requires antibiotic use.
  • Any other factor during the surgery which the surgeon estimates requires prophylactic antibiotic use.
  • Allergy to cephalosporins and allergy to penicillin which precludes the use of cephalosporins (e.g. anaphylaxis).

研究组 & 干预措施

Cefazolin

Active Comparator

Cefazolin

1 gram/2 gram if body mass index > 40 - one time dose, 30-60 min prior to incision.

干预措施: Cefazolin (Drug)

Placebo

Placebo Comparator

1 dose of placebo - NaCl 0.9% with no drugs added to it.

干预措施: Placebo (Drug)

结局指标

主要结局

Surgical wound infection, sepsis, bacteremia.

时间窗: 1 month from surgery

次要结局

  • Length of stay(1 month from surgery)
  • Drug-induced adverse reactions(1 month from surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

yotam shkedy

Resident

Rabin Medical Center

研究点 (1)

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