Sakurai Shiori, Kawamura Yuji, Nohmi Eri, Kokubo Takemasa, Koikeda Takashi
Medical Regulatory Affairs, NICHIBAN Co. Ltd., Tokyo, JPN.
Quality Assurance, NICHIBAN Co. Ltd., Tokyo, JPN.
Cureus. 2024 Oct 29;16(10):e72600. doi: 10.7759/cureus.72600. eCollection 2024 Oct.
Objective This study aimed to compare the adhesion of CATHEREEPLUS Pad (CPSP; NICHIBAN Co., Ltd., Tokyo, Japan) and Tegaderm +Pad (TGMP; 3M, Maplewood, MN, USA) film dressings on the forearm skin of healthy participants over a four-day application period. Methods Twenty-six randomly assigned participants received CPSP dressing on one arm and TGMP on the other. The primary endpoint was adhesion to the skin after four days of dermal application. Secondary endpoints were adhesion and itchiness during the application period, pain experienced during dressing removal, skin maceration, adhesive residue immediately post-dressing removal, and skin reactions at one and 24 hours post-dressing removal. All endpoints were evaluated using a five- or six-point scoring system. Results Following four days of dressing application, 77% of participants in the CPSP group and 73% of those in the TGMP group scored 4 (most) or 5 (complete) for adhesion. No clinically significant problems such as itchiness, pain, skin maceration, adhesive residue, or skin reactions were observed in either group. No statistically significant differences in any of the endpoints were observed between the two groups. Conclusion Both CPSP and TGMP dressings showed good adhesion to the skin during four days of dermal application in healthy participants, with no significant difference in adhesion observed between the two groups.
目的 本研究旨在比较CATHEREEPLUS垫(CPSP;日本东京日东纺绩株式会社)和泰德思膜+垫(TGMP;美国明尼苏达州枫树wood市3M公司)薄膜敷料在健康受试者前臂皮肤上应用四天期间的粘附情况。方法 26名随机分组的受试者,一只手臂使用CPSP敷料,另一只手臂使用TGMP敷料。主要终点是皮肤应用四天后的皮肤粘附情况。次要终点是应用期间的粘附和瘙痒情况、去除敷料时经历的疼痛、皮肤浸渍、去除敷料后立即出现的粘性残留物以及去除敷料后1小时和24小时的皮肤反应。所有终点均使用五分或六分评分系统进行评估。结果 敷料应用四天后,CPSP组77%的受试者和TGMP组73%的受试者在粘附方面得分为4(最多)或5(完全)。两组均未观察到瘙痒、疼痛、皮肤浸渍、粘性残留物或皮肤反应等具有临床意义的问题。两组在任何终点方面均未观察到统计学上的显著差异。结论 在健康受试者皮肤应用四天期间,CPSP和TGMP敷料均对皮肤表现出良好的粘附性,两组之间在粘附方面未观察到显著差异。