一项比较新鲜复合骨折传统治疗方案与循证治疗方案的随机对照研究。
A Randomized Controlled Study to Compare Conventional and Evidence Based Treatment Protocols in Fresh Compound Fractures.
作者信息
Mahajan Kanika, Verma Vikas, Singh Girish Kumar, Kumar Santosh, Avasthi Sachin
机构信息
PhD, Department of Orthopedic Surgery, King George's Medical University , Lucknow, Uttar Pradesh, India .
Associate Professor, Department of Orthopedic Surgery, Era's Lucknow Medical College and Hospital , Lucknow, Uttar Pradesh, India .
出版信息
J Clin Diagn Res. 2016 Sep;10(9):RC01-RC05. doi: 10.7860/JCDR/2016/19234.8405. Epub 2016 Sep 1.
INTRODUCTION
A recent concept review in Journal of Bone and Joint Surgery (JBJS) outlines evidence to control peri-operative infections in compound fractures. However, evidence for impact of adopting a protocol combining measures that have some evidence is lacking in literature. The present method of treatment at King George's Medical University (KGMU) is representative of the conventional practice of managing compound fractures in India and is an appropriate control for trial against the Experimental Evidence Based Protocol (EBP).
AIM
To study the additional impact of adopting Evidence Based Protocol on parameters defining infection rate and bone union.
MATERIALS AND METHODS
This randomized controlled study was conducted at the orthopaedics department of KGMU. Two hundred and twenty six patients of compound fractures of both bone leg, age > 12y were randomized to two groups. One group received standard treatment and the experimental group received treatment as per JBJS review.
STATISTICAL ANALYSIS
Random allocation was tested by comparing baseline characteristics of the two groups. The two groups were compared for all the outcome variables in terms of time to a negative wound culture, time to wound healing, time to union at fracture site and time to achieve complete range of motion at knee joint.
RESULTS
Random allocation was successful. EBP group reported significantly lesser time to a negative culture report from wound (mean in conventional=4.619, experimental=1.9146, p=0.0006), lesser time to bony union (mean in conventional=23.8427 weeks, experimental=22.8125 weeks, p=0.0027), lesser time to wound healing (mean in conventional=14.4425 weeks experimental=10.4513 weeks, p=0.0032), and a lesser duration of hospital stay (mean in conventional=6.5982 days, experimental=4.5000 days, p=0.0343).
CONCLUSION
EBP based on the guidelines suggested by Fletcher et al., significantly shorten the time taken for achieving a negative culture and hasten wound and fracture healing. Therefore EBP is recommended for use in settings like the KGMU trauma center.
引言
《骨与关节外科杂志》（JBJS）最近的一篇概念综述概述了控制复合骨折围手术期感染的证据。然而，文献中缺乏关于采用一种结合了一些有证据支持的措施的方案所产生影响的证据。乔治国王医科大学（KGMU）目前的治疗方法代表了印度处理复合骨折的传统做法，是与基于实验证据的方案（EBP）进行试验的合适对照。
目的
研究采用循证方案对定义感染率和骨愈合的参数的额外影响。
材料与方法
这项随机对照研究在KGMU骨科进行。226例双下肢复合骨折、年龄>12岁的患者被随机分为两组。一组接受标准治疗，实验组按照JBJS综述进行治疗。
统计分析
通过比较两组的基线特征来检验随机分配情况。比较两组在伤口培养转阴时间、伤口愈合时间、骨折部位愈合时间以及膝关节达到完全活动范围时间等所有结局变量方面的情况。
结果
随机分配成功。EBP组报告伤口培养转阴报告的时间显著更短（传统组均值=4.619，实验组=1.9146，p=0.0006），骨愈合时间更短（传统组均值=23.8427周，实验组=22.8125周，p=0.0027），伤口愈合时间更短（传统组均值=14.4425周，实验组=10.4513周，p=0.0032），住院时间更短（传统组均值=6.5982天，实验组=4.5000天，p=0.0343）。
结论
基于弗莱彻等人建议的指南的EBP显著缩短了实现培养转阴所需的时间，并加速了伤口和骨折愈合。因此，建议在KGMU创伤中心等环境中使用EBP。
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