一次性脉冲冲洗吸引器应用于创面清创的前瞻性随机对照研究

Effect of disposable electronically pulsed lavage suction apparatus in wound cleansing

目的探讨一次性脉冲冲洗吸引器应用于创阿清创的临床疗效，并评价其安全性。方法采用随机单盲对照的临床试验方法进行临床观察，将2009年4月至2010年1月收治的51例受试者随机分为两组：试验组26例，男22例，女4例；年龄20～61岁，平均（43．2±14．1）岁。感染创面面积为5cm×6cm～26cm×32cm。均采用一次性电动脉冲冲洗吸引器进行清创。对照组25例，男19例，女6例；年龄19～57岁，平均（40．3±16．5）岁。感染创面面积为6cm×8cm～25cm×34cm。采用生理盐水直接冲洗进行清创。对获随访患者的临床资料进行分析，以术后2周伤口周围的炎性反应和菌溶计数情况评估冲洗后的疗效。结果51例患者均获得随访，随访时问为2周。试验组与对照组患者冲洗后伤口周围红、肿、热临床症状改变及菌落计数（4992±19640vs.21000±1996089）差异均无统计学意义（P〉0．05）；试验组伤口渗液较对照组明显变轻，差异有统计学意义（x^2=4．306，P=0．012）。试验组冲洗后伤口菌落计数（4992±19640）较冲洗前（423000±19538889）明显减少，差异有统计学意义（t=10．214，P=0．002）。试验前后无不良反应发生。结论一次性电动脉冲冲洗吸引器冲洗伤口与传统冲洗方法一样有效、安全，且具有减少手术后创面渗液、使用方便的优点，有一定推广价值。

Objective To evaluate the clinical effect and safety of disposable electronically pulsed lavage suction apparatus in wound cleansing in a randomized single-blinded trial. Methods From April 2009 through January 2010, 51 patients were randomized into experimental and control groups. In the control group, wounds were debrided by flushing with normal saline directly. In the experimental group, wounds were cleansed with disposable electronically pulsed lavage suction apparatus. The clinical effects were evaluated in terms of inflammatory reaction and colony count around the wound 2 weeks after wound cleansing. Results All cases were followed up for 2 weeks. No significant differences were found between the 2 groups in the inflammatory reaction or in the colony count （4992 ± 19 640 vs. 21 000 ± 1 996 089） 2 weeks after wound cleansing （ P 〉 0. 05）. The wound effusion in the experimental group was signific.antly less than in the control group （x^2 = 4. 306, P = 0. 012）. In the experimental group, the colony count after wound cleansing （4992 ± 19 640） was significantly smaller than that before wound cleansing （423 000 ± 19 538 889） （ t = 10. 214, P = 0. 002） . No untoward reaction happened in this clinical trial. Conclusions Disposable electronically pulsed lavage suction apparatus is as effective and safe as the traditional method. Since the pulses lavage can decrease postoperative wound effusion and is convenient to use, it is recommendable in clinic.