临床试验/NCT01222832

NCT01222832已完成2 期

Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge After Functional Endoscopic Sinus Surgery

Steward St. Elizabeth's Medical Center of Boston, Inc.1 个研究点分布在 1 个国家目标入组 226 人开始时间: 2010年7月最近更新: 2017年5月31日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Steward St. Elizabeth's Medical Center of Boston, Inc.
入组人数: 226
试验地点: 1
主要终点: Rate of Infection

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS a sponge soaked in Saline / and the administration of oral antibiotics.

详细描述

Same as above

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: 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: 否

入选标准

•Patient having primary or revision sinus surgery. Aged 18 years or older.Patients must have middle meatus easily identified. The type of surgery will not be influenced by the participation in this study.

排除标准

•Age less then 18
•Known sensitivity to Bacitracin
•Pregnancy

研究组 & 干预措施

Bacitracin

Experimental

Nasopore sponge soaked in Bacitracin, no oral antibiotics

干预措施: Bacitracin (Drug)

结局指标

主要结局

Rate of Infection

时间窗: 90 days

Number of participants without infections on post-op visits 90 days.

次要结局

未报告次要终点

研究者

发起方

Steward St. Elizabeth's Medical Center of Boston, Inc.

申办方类型

Other

责任方

Principal Investigator

主要研究者

Peter Catalano

Chief of Otolaryngology

Steward St. Elizabeth's Medical Center of Boston, Inc.

研究点 (1)

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