在换药疼痛方面，浸渍醋酸纱布与脂质胶体接触层的比较：一项单盲交叉随机对照试验。

Impregnated acetate gauze compared with lipido-colloid contact layer at dressing removal pain: a single-blind cross-over randomised control trial.

作者信息

Meaume Sylvie, Thomas Pierre, Truchetet François, Celerier Philippe, Becherel Pierre-André, Teot Luc, Bedane Christophe

机构信息

Dermatologist and Geriatrician, Head of Geriatric Department and Wound Care Unit; Rothschild University Hospital, Paris, France.

Dermatologist; Hôpital Claude Huriez, Lille, France.

出版信息

J Wound Care. 2019 Feb 2;28(2):89-101. doi: 10.12968/jowc.2019.28.2.89.

DOI:10.12968/jowc.2019.28.2.89

PMID:30767647

Abstract

OBJECTIVE

To evaluate the performance of Jelonet Plus (JP) and UrgoTul (UT), assessing pain at dressing removal when managing acute or chronic wounds at granulation and epithelialisation stages.

METHODS

This was a randomised, multicentre, controlled single-blinded study using a cross-over design. Hospitalised and ambulatory patients presenting with non-infected acute or chronic wounds (at least 40% of wound area of ≤100cm covered with granulation tissue) were randomly allocated to be treated with either JP or UT dressings applied according to a standardised local care procedure for two days. At the following visit, patients received the other dressing for a second 2-day period. Pain was evaluated after two days of dressing application and immediately after its removal using a 100mm Visual Analog Scale (VAS). A pain level >30mm was considered as clinically relevant. A lower limit of -12% was determined as the threshold necessary to demonstrate the non-inferiority of JP compared to UT.

RESULTS

For the 99 patients completing the study, a difference of 7.9% was observed in favour of JP (83.8% JP versus 75.9% UT) for pain immediately after dressing removal (VAS score < 30mm) with a confidence interval (CI) lower limit of -2.6%, demonstrating non-inferiority (pre-defined limit of -12%). Concerning pain at dressing removal, a difference of 19.6% was observed in favour of JP (81.6% versus 62.0%; p=0.029 for superiority analysis), with a CI lower limit ranging from 2.4% to 38.9%. Therefore, superiority could be concluded. A statistically significant period effect was detected (p=0.003) with fewer patients experiencing pain after the second period day 2 (D2) to day 4 (D4) than the first day 0 (D0) to D2. A statistically significant cross-over effect was also detected (p=0.047), with fewer patients experiencing pain when JP was applied first followed by UT. This suggests a carry-over effect thus preventing a full cross-over design analysis. Adherence of the dressing was less frequent with the JP than the UT dressing (2.0% JP versus 6.9% with UT).

CONCLUSION

Non-inferiority of pain at dressing removal was demonstrated with JP. Superiority on this criteria was non-significant but we found adherence of the dressing to the wound bed to be more rare.

摘要

目的

评估Jelonet Plus（JP）和UrgoTul（UT）在处理处于肉芽形成和上皮形成阶段的急性或慢性伤口时，去除敷料时的疼痛表现。

方法

这是一项采用交叉设计的随机、多中心、对照单盲研究。住院和门诊患者，患有未感染的急性或慢性伤口（至少40%的伤口面积≤100平方厘米，覆盖有肉芽组织），被随机分配接受JP或UT敷料治疗，按照标准化的局部护理程序应用两天。在接下来的就诊时，患者接受另一种敷料治疗，为期两天。在敷料应用两天后以及去除后立即使用100毫米视觉模拟量表（VAS）评估疼痛。疼痛水平>30毫米被认为具有临床相关性。确定下限为-12%作为证明JP相对于UT非劣效性所需的阈值。

结果

对于完成研究的99名患者，在去除敷料后立即评估疼痛时（VAS评分<30毫米），观察到有利于JP的差异为7.9%（JP为83.8%，UT为75.9%），置信区间（CI）下限为-2.6%，证明了非劣效性（预定义下限为-12%）。关于去除敷料时的疼痛，观察到有利于JP的差异为19.6%（81.6%对62.0%；优势分析p=0.029），CI下限范围为2.4%至38.9%。因此，可以得出优势结论。检测到统计学上显著的时期效应（p=0.003），与第0天（D0）至第2天（D2）的第一个时期相比，在第二个时期第2天（D2）至第4天（D4）经历疼痛的患者更少。还检测到统计学上显著的交叉效应（p=0.047），先应用JP然后应用UT时经历疼痛的患者更少。这表明存在残留效应，从而妨碍了全面的交叉设计分析。JP敷料的贴合性比UT敷料更低（JP为2.0%，UT为6.9%）。