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临床试验/NCT04946435
NCT04946435撤回1 期

Evaluating the Effect of Prophylactic Topical Antibiotic Irrigation on Nasal Packing Colonization Following Endoscopic Skull Base Surgery

Carl Snyderman2 个研究点 分布在 1 个国家开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
1 期
状态
撤回
发起方
试验地点
2
主要终点
Which bacteria colonize nasal packing following endoscopic skull base surgery

研究概览

简要总结

This is an interventional study that will examine the effect of prophylactic topical antibiotics on nasal packing colonization following endoscopic skull base surgery.

详细描述

Following endoscopic skull base surgery (ESBS), nasal packing is used to control bleeding and to support reconstruction but can be a source for possibly infectious colonization. Antibiotic use and selection in ESBS varies largely and topical antibiotics are not routinely employed despite favorable qualities (i.e. direct delivery of high antibiotic concentrations with low adverse systemic effects). The effect of prophylactic topical antibiotics on nasal packing colonization is currently understudied. A larger study is needed to test the validity of the conclusion. Employing a larger sample size undergoing ESBS (which does not directly act on the nasal cavity), the investigators hope to amend the lack of literature evaluating the effect of prophylactic topical antibiotics on nasal packing post-ESBS. THe investigators hope to contribute to the determination of an ideal antibiotic regimen following ESBS, which may be especially beneficial for immunocompromised patients or patients at risk of post-surgery infections such as meningitis. Furthermore, the effect of ESBS on the nasal flora is largely understudied, with limited literature only reporting on the nasal flora following endoscopic sinus surgery (ESS). The investigators hope to also amend the lack of literature exploring the effects of ESBS on the nasal flora, especially long-term effects that may be examined in patients undergoing revision surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Patients undergoing primary or revision endoscopic skull base surgery
  • Sellar or Intracranial pathology

排除标准

  • Patients with sinonasal malignancy
  • Prior radiation therapy
  • Concurrent sinusitis and/or nasal polyposis

结局指标

主要结局

Which bacteria colonize nasal packing following endoscopic skull base surgery

时间窗: 1 year

The bacteria making up the colonization of nasal packing post-endoscopic skull base surgery will be identified using culture analysis.

Can prophylactic topical antibiotics alter the colonization of nasal packing following endoscopic skull base surgery

时间窗: 1 year

The effect of prophylactic topical antibiotics on nasal packing colonization post-endoscopic skull base surgery will be measured using culture analysis. Colonization will be described as type(s) of bacteria.

Can prophylactic topical antibiotics alter the bacterial load of nasal packing following endoscopic skull base surgery

时间窗: 1 year

The effect of prophylactic topical antibiotics on the bacterial load of nasal packings post-endoscopic skull base surgery will be measured using culture analysis. Bacterial load will be measured in colony forming units (CFUs).

次要结局

  • Does endoscopic skull base surgery later the nasal flora(1 year)

研究者

发起方
Carl Snyderman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Carl Snyderman

Professor

University of Pittsburgh

研究点 (2)

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