Meaume Sylvie, Thomas Pierre, Truchetet François, Celerier Philippe, Becherel Pierre-André, Teot Luc, Bedane Christophe
Dermatologist and Geriatrician, Head of Geriatric Department and Wound Care Unit; Rothschild University Hospital, Paris, France.
Dermatologist; Hôpital Claude Huriez, Lille, France.
J Wound Care. 2019 Feb 2;28(2):89-101. doi: 10.12968/jowc.2019.28.2.89.
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.
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.
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).
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.
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。
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。
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%）。
JP在去除敷料时的疼痛方面证明了非劣效性。在这一标准上的优势不显著，但我们发现敷料与伤口床的贴合性更少见。
