Antibiotic prophylaxis in clean and clean-contaminated ear surgery

 

Abstract

Background

This is an update of a Cochrane Review first published in Issue 3, 2004 and previously updated in 2007.

Ear surgery may be performed in the treatment of chronic otitis media, ossicular chain disorders, tympanic membrane perforations and otitis media with effusion. Postoperative infection in ear surgery may result in wound infections, infection of the middle ear or mastoid resulting in discharge from the ear canal, failure of the tympanic membrane to close, or labyrinthitis due to infection in, or adjacent to, the inner ear. These complications may be associated with discomfort and inconvenience for the patient, an increase in morbidity and an increase in the costs of medical care.

Objectives

To assess the effects of local and/or systemic antibiotics for preventing complications such as postoperative discharge, graft failure and labyrinthitis in patients undergoing clean or clean-contaminated ear surgery.

Search methods

We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, CINAHL, Web of Science, BIOSIS Previews, Cambridge Scientific Abstracts, mRCT and additional sources for published and unpublished trials. The date of the most recent search was 31 August 2009.

Selection criteria

Randomised or quasi-randomised trials involving patients undergoing clean or clean-contaminated types of ear surgery. Skull base surgery was excluded. We included any regimen of local and/or systemic antibiotic prophylaxis administered at or around the time of surgery compared to placebo, no antibiotic or an alternative intervention group. Outcome measures were infection, discharge, graft failure, labyrinthitis and adverse effects of prophylaxis.

Data collection and analysis

When possible, we contacted investigators for additional information on data and methodological issues. At least two authors independently extracted data and assessed trial quality.

Main results

Eleven studies were included in the review. The methodological quality of the trials was fair to good. However, most studies presented insufficient methodological detail. Although definitions of outcome measures were heterogeneous, pooling of results was possible. There were no significant differences between antibiotic prophylaxis groups and control groups in terms of reduction of postoperative infections, graft failures, draining outer ear canals and adverse drug effects.

Authors' conclusions

There is no strong evidence that the large-scale use of prophylactic antibiotics in clean and clean-contaminated ear surgery is helpful in reducing postoperative complications such as wound infection, discharge from the outer ear canal, labyrinthitis and graft failure.

 

Plain language summary

Preventative antibiotics (prophylaxis) in clean and clean-contaminated ear surgery

Ear surgery, as surgery in general, can be divided into several categories: clean, clean-contaminated, contaminated and dirty surgery. Postoperative complications can include wound infection, discharge from the outer ear canal, labyrinthitis and graft failure. This review aimed to demonstrate whether the use of antibiotic prophylaxis in ear surgery can be helpful in reducing postoperative complications in clean or clean-contaminated surgery. There is no current evidence from randomised controlled trials showing that there is any antibiotic substance, in any regime, which can contribute to reducing complications in any type of clean or clean-contaminated surgical procedure in the ear.

 

摘要

背景

預防性抗生素在乾淨(clean)及乾淨污染性(cleancontaminated)耳朵手術的應用

耳朵手術可用於治療慢性中耳炎(chronic otitis media),聽小骨鏈病變遷(ossicular chain disorders),鼓膜穿孔(tympanic membrane perforations)及中耳腔積液(otitis media with effusion).耳朵手術術後發炎可導致:傷口感染，中耳或乳突感染造成分泌物從耳道流出，鼓膜無法癒合或因內耳或內耳附近的感染引起內耳迷路炎(Labyrinthitis)．這些併發症可能會造成病人不適和不便，增加發病率及醫療成本

目標

針對接受清潔或清潔污染耳部手術的患者，全身性及(或)局部性抗生素對於預防併發症(如：手術後出院、植入物失效以及迷路炎)的效果

搜尋策略

搜尋Cochrane Ear, Nose and Throat Disorders Group Trials Register、Cochrane Central Register of Controlled Trials (CENTRAL)、 PubMed、EMBASE、CINAHL、Web of Science、 BIOSIS Previews、 Cambridge Scientific Abstracts、mRCT及其他文獻來源以找出未發表及已發表的試驗。迄至目前為止最近一次的搜尋時間時是2009年8月31日

選擇標準

Randomised or quasirandomised trials包括了： 參加者： 接受乾淨及乾淨污染性耳朵手術的病人， 顱底手術被排除． 介入方式： 在手術開始時或靠近時間，給予任何局部及／或全身性預防性抗生素，比上安慰組，或沒有給予抗生素，或是給多其他介入方式的組別。 結果測量方法： 感染，分泌物，植入物失效，內耳迷路炎，預防性抗生素投予造成的副作用

資料收集與分析

在允許的情況下會聯絡專家們，以獲得進一步跟資料及研究方法的相關資訊。至少兩位作者獨立進行了資料抽查及評估試驗的品質

主要結論

11個符合要求的研究被納入此回顅，其研究方法的品質為普通到良好。可是大部份研究沒有提供足夠的研究方法的詳細資料。雖然研究結果的定義不一，但仍可以共用進行分析．在減低術後感染、植入物失效、外耳道分泌物及藥物副作用等各方面，投予預防性抗生素組及控制組之間沒有顯著差異

作者結論

目前沒有強力證據顯示，在乾淨及乾淨污染性耳朵手術中，大規模使用預防性抗生素可減低術後併發症，如傷口感染，外耳道分泌物，內耳迷路炎及植入物失效

翻譯人

本摘要由國泰綜合醫院尹丹桂翻譯

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌

總結

沒有強力證據顯示，在耳朵手術中，大規模使用預防性抗生素可減低術後併發症。耳朵生術，如一般手術，可分為幾個類別：乾淨，乾淨污染，污染及骯髒如傷口感染，外耳道分泌物，內耳迷路炎及植入物失效。術後併發症包括了，如傷口感染，外耳道分泌物，內耳迷路炎及植入物失效。此回顧的目的在於顯示在乾淨或乾淨污染的性耳朵手術，使用預防性抗生素能否減低術後併發症。目前所有相關的randomised controlled trials 的結果顯示，沒有任何一種抗生素配方可有助減低乾淨或乾淨污染耳朵手術的併發症