Department of Orthopedics and Trauma Surgery, University Hospital Cologne, Germany; Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Germany; Spine Surgery, Schön Klinik Düsseldorf SE & Co. KG, Düsseldorf, Germany.
Dtsch Arztebl Int. 2018 Mar 30;115(13):213-219. doi: 10.3238/arztebl.2018.0213.
Lower-limb endoprosthetic operations and spinal operations are among the more common types of orthopedic procedures. Postoperative woundhealing disturbances and infections can lead to longer periods of hospital stay and recovery as well as to higher morbidity and mortality.
209 patients who had been judged to have an indication for a primary knee or hip endoprosthesis or for a primary spinal operation were included in this randomized trial (ClinicalTrials.gov: NCT01988818) over the period June 2014- February 2015. After randomization, patients in the intervention group were given a trial dressing (Mepilex-Border Post-Op) and those in the control group were given a conventional adhesive dressing (Cosmopor). The primary endpoint was blister formation.
In the overall study population, only a single case of blister formation was seen. The affected patient belonged to the intervention group but was mistakenly given a control dressing and developed blisters on the 6th day after surgery. Dressings were changed less frequently in the intervention group, and this difference was statistically significant (p<0.001). The patients, nurses, and physicians all expressed greater satisfaction with the trial dressings than with the control dressings (p<0.001).
The intervention group did not differ from the control group with respect to the primary endpoint, postoperative blister formation. The patients, nurses, and physicians all judged the dressing used in the intervention group more favorably than the conventional dressing.
下肢假体手术和脊柱手术是常见的骨科手术类型之一。术后伤口愈合障碍和感染会导致住院时间和康复时间延长，发病率和死亡率升高。
本随机试验（ClinicalTrials.gov：NCT01988818）纳入了 209 名患者，这些患者被认为有进行初次膝关节或髋关节假体手术或初次脊柱手术的指征。在 2014 年 6 月至 2015 年 2 月期间，试验组患者使用试用敷料（Mepilex-Border Post-Op），对照组患者使用常规粘性敷料（Cosmopor）。主要终点为水疱形成。
在总体研究人群中，仅观察到 1 例水疱形成。受影响的患者属于干预组，但错误地使用了对照组的敷料，并在手术后第 6 天出现水疱。干预组的敷料更换频率较低，差异具有统计学意义（p<0.001）。患者、护士和医生均表示试用敷料比对照组敷料更满意（p<0.001）。
干预组与对照组在主要终点即术后水疱形成方面没有差异。患者、护士和医生均认为干预组使用的敷料比常规敷料更优。
