弗洛塞尔（®）止血剂在头颈外科手术中的安全性试验。
Safety trial of Floseal(®) haemostatic agent in head and neck surgery.
作者信息
Ujam A, Awad Z, Wong G, Tatla T, Farrell R
机构信息
North West London Hospitals NHS Trust, UK.
出版信息
Ann R Coll Surg Engl. 2012 Jul;94(5):336-9. doi: 10.1308/003588412X13171221590971.
INTRODUCTION
Floseal(®) can be of value in reducing blood loss and haematoma rates. The manufacturer's warnings include allergic reaction, poor wound healing and intravascular thrombosis. We aimed to determine whether Floseal(®) is safe to use in various head and neck surgery procedures.
METHODS
A prospective trial was conducted using Floseal(®) in 42 various consecutive head and neck surgery procedures. Adverse incidents were used as the main outcome measure, including allergic reaction, wound breakdown, wound infection and thrombosis. Secondary outcome measures included haematoma formation, hospital stay, drain times and output.
RESULTS
No adverse incidents were recorded in the trial period. Two patients developed haematomas and required surgical exploration where a bleeding vessel was identified and dealt with.
CONCLUSIONS
Floseal(®) is safe to be used in head and neck surgery with no adverse effects. A larger number and a control group are required to ascertain its value in reducing blood loss, haematoma formation, drain usage and hospital stay.
引言
弗洛塞尔（Floseal）在减少失血和血肿发生率方面可能具有价值。制造商的警告包括过敏反应、伤口愈合不良和血管内血栓形成。我们旨在确定弗洛塞尔在各种头颈外科手术中使用是否安全。
方法
对42例连续进行的各种头颈外科手术使用弗洛塞尔进行前瞻性试验。不良事件用作主要结局指标，包括过敏反应、伤口裂开、伤口感染和血栓形成。次要结局指标包括血肿形成、住院时间、引流时间和引流量。
结果
试验期间未记录到不良事件。两名患者出现血肿，需要进行手术探查，术中发现并处理了出血血管。
结论
弗洛塞尔用于头颈外科手术是安全的，无不良影响。需要更多病例数和设立对照组来确定其在减少失血、血肿形成、引流使用和住院时间方面的价值。
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