A Randomized, Comparative Study of Skin Adhesion Between CATHEREEPLUS Pad and Tegaderm Pad Film Dressings in Healthy Participants.

Shiori Sakurai, Yuji Kawamura, Eri Nohmi, Takemasa Kokubo, Takashi Koikeda
Author Information
  1. Shiori Sakurai: Medical Regulatory Affairs, NICHIBAN Co. Ltd., Tokyo, JPN.
  2. Yuji Kawamura: Medical Regulatory Affairs, NICHIBAN Co. Ltd., Tokyo, JPN.
  3. Eri Nohmi: Medical Regulatory Affairs, NICHIBAN Co. Ltd., Tokyo, JPN.
  4. Takemasa Kokubo: Quality Assurance, NICHIBAN Co. Ltd., Tokyo, JPN.
  5. Takashi Koikeda: Dermatology, Shiba Palace Clinic, Tokyo, JPN.

Abstract

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.

Keywords

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