Reducing radiation dermatitis during ongoing radiation therapy: an innovative film-forming wound dressing

Abstract

This multicenter study focuses on the use of a film-forming wound dressing in the form of a gel that can be applied directly to the area affected by radiation dermatitis, especially after skin breakdown. The primary objective of the study was to validate the efficacy of an innovative film-forming wound dressing used as monotherapy in the treatment of radiation dermatitis in patients with RTOG score 2.5 (± 0.5) confirmed by the investigator. Fifty-four patients undergoing radiation therapy for different cancer types and developing radiation dermatitis were recruited in the study; they were treated with the film-forming wound dressing when reaching an RTOG score of 2.5 (± 0.5). The evaluation of radiation dermatitis during ongoing radiation therapy was performed using the RISRAS, which includes investigator-assessed items (erythema, dry desquamation, moist desquamation, necrosis) and patient-assessed items (pain, itch, burning sensation, affection of daily activities). The following study shows a statistically significant clinical improvement (p < 0.05) of the RISRAS score (− 16.9%), as well as of specific clinical outcomes, such as erythema (− 20.6%), pain (− 20.5%), itch (− 22.2%), and burning sensation (−24.7%), after the treatment with the film-forming wound dressing during ongoing radiation therapy. Other radiation dermatitis markers, such as inflammation (− 28.9%) and hydration (26.0%), appeared to be significantly influenced. The use of the innovative film-forming wound dressing for radiation dermatitis treatment shows first time evidence of improving the RISRAS score during ongoing radiation therapy, showing major improvements in patients’ quality of life.