Background

Active warming during surgery prevents perioperative hypothermia but the effectiveness and post-operative infection rates may differ between warming technologies. We report results of a pilot study in patients over the age of 65 undergoing hemiarthroplasty following fractured neck of femur.

Aim

To establish the recruitment and data management strategies needed for a full trial comparing post-operative infection rates associated with forced air versus resistive fabric warming.

Methods

Participants were randomised 1:1 in permuted blocks to forced air or resistive fabric warming. Hypothermia was defined as a temperature of <36ºC at the end of surgery. Primary outcomes were the number of participants recruited and the number with definitive deep surgical site infections.

Findings

515 participants were randomised at 6 sites over a period of 18 months. Follow-up was completed for 70.1%. Thirty-seven participants were hypothermic (7.5% in the FAW group; 9.7 % in the RFW group). The mean temperatures before anaesthesia and at the end of surgery were similar. For the primary clinical outcome, there were 4 deep surgical site infections in the forced air warming group and 3 in the resistive fabric warming group. All participants who developed a post-operative infection had antibiotic prophylaxis, a cemented prosthesis and were operated under laminar airflow; none were hypothermic. There were no serious adverse events related to warming.

Conclusion

Surgical site infections were identified in both groups. Progression from the pilot to the full trial is possible but will need to take account of the high attrition rate.

Trial Registration

ISRCTN 74612906 (http://www.isrctn.com/ISRCTN74612906)

中文翻译：

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减少骨科的种植体感染（RIIiO）：一项比较研究的结果，该研究比较了强制空气和电阻织物加温技术对骨科植入物手术后手术后感染的影响

背景

手术期间的主动加温可以防止围手术期的体温过低，但是加热技术之间的效果和术后感染率可能有所不同。我们报告了在65岁以上的股骨颈骨折后接受半髋置换术的患者中进行的一项初步研究的结果。

目的

为了建立全面试验所需的募集和数据管理策略，以比较与强制通风和电阻织物加热相关的术后感染率。

方法

参与者按照置换块的1：1比例随机分配给强制通风或电阻织物加热。体温过低定义为手术结束时温度低于36ºC。主要结局是招募的参与者人数和发生明确的深部手术部位感染的人数。

发现

在18个月的时间里，将515名参与者随机分配到6个地点。随访完成率为70.1％。37名参与者进行了体温过低（一汽组为7.5％； RFW组为9.7％）。麻醉前和手术结束时的平均温度相似。对于主要的临床结果，在强制空气加热组中有4例深层手术部位感染，在电阻织物加热组中有3例。所有发生术后感染的参与者均进行了抗生素预防和固定的假体，并在层流气流下进行了手术。没有人是低温的。没有与变暖相关的严重不良事件。

结论

两组均发现手术部位感染。从飞行员到全面试用是可能的，但需要考虑到高的流失率。

试用注册

ISRCTN 74612906（http://www.isrctn.com/ISRCTN74612906）