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Background: Blister plasters are non-invasive and non-sterile dressings composed of a hydrocolloid layer held in place by a polyurethane film and a non-touch foil that provides an ideal healing environment. Their intended use is the protection of blisters providing immediate relief of pain and pressure, cushioning and protection against rubbing. This study was designed to generate additional data to further support some of the main claims of hydrocolloid blister plasters (COMPEED® BLISTER), in a real-life setting. Methods: The study was a multinational (UK, Spain, Russia), prospective, non-randomised, parallel group comparison of hydrocolloid blister plasters (also called specialist plasters) and standard plasters in real time. Data were collected daily from the time at which participants developed blisters over the following 8-day period. Results: The cut-off of 50% of participants experiencing pain relief was set to signify that the hydrocolloid blister plaster provided effective pain relief. This cut-off was statistically significantly exceeded (55.8% ± 5.1; p<0.05) immediately after plaster application, indicating that the specialist plaster provided immediate and sustained pain relief. Specialist plasters consistently outperformed standard plasters in terms of efficacy (pain relief, time to healing), efficiency (cushioning, adhesion, wear time) and satisfaction. Participants gave hydrocolloid blister plasters significantly higher overall satisfaction ratings than for the standard plasters and nearly all participants would use the specialist plaster again and would recommend them to friends and family. Finally, the hydrocolloid blister plaster was comparable to the standard plaster in terms of safety (solicited and unsolicited adverse events). Conclusions: The primary objective of this study, to validate the superiority of the specialist plaster in terms of immediate pain relief, was clearly achieved. Further, hydrocolloid blister plasters’ superiority in terms of pain relief, adhesion, wear time, cushioning and time to healing were demonstrated. The comparative claim of faster healing, was fully supported by data from participants in each country where it was possible to effectively evaluate healing time. *Correspondence to: Paul Carter, HRA Pharma, 200 avenue de Paris, 92320, Chatillon, France, E-mail: c.carter@hra-pharma.com

clinical research and trials

Hydrocolloid blister plasters vs. standard plasters for foot blisters treatment in real life: a comparative, non-randomised, international, superiority study