临床试验/NCT01264003

NCT01264003已完成4 期

Single Dose Antibiotic Prophylaxis in Lihtenstein Repair for Primary Inguinal Hernias

Diskapi Teaching and Research Hospital0 个研究点目标入组 200 人开始时间: 2008年5月最近更新: 2010年12月21日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Diskapi Teaching and Research Hospital
入组人数: 200
主要终点: Surgical site 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记录与标识符相似试验

研究概览

简要总结

Inguinal hernia repairs is clean surgical procedures. However infection may be a concern when prosthetic materials are used. This prospective randomized study has been set to observe if antibiotic prohylaxis is of benefit in mesh repair of inguinal hernias.

详细描述

There are two group in the study. Control group received no antibiotic prohylaxis, whereas a single dose 1 gr. intravenous cefazoline is given to the patient in prophylaxis arm of the study. 30-days surgical site infection rates and 1 year prosthetic intervention late infection rates are observed and recorded. Side effects of antibiotic used are also recorded.

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, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•inguinal hernia repair -

排除标准

•uncontrolled diabetes mellitus,

研究组 & 干预措施

1

Active Comparator

Antibiotic prohylaxis / Lichtenstein repair

干预措施: sefazolin (Drug)

结局指标

主要结局

Surgical site infection

时间窗: 30 days postoperatively

次要结局

Drug side effects(5 days postoperatively)
1-year prosthetic repair surgical site late infection rate(1 year)

研究者

发起方

Diskapi Teaching and Research Hospital

申办方类型

Other

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