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

  • Original Research
  • Published:
Journal of Radiation Oncology

Abstract

Objective

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.

Methods

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).

Results

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.

Conclusion

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.

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Abbreviations

CRF:

Case report form

GCP:

Good clinical practice

PIL:

Patient information leaflet

RISRAS:

Radiation-Induced Skin Reaction Assessment Scale

RTOG:

Radiation Therapy Oncology Group

SD:

Standard deviation

SEM:

Standard error mean

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Author information

Authors and Affiliations

  1. Fundación Instituto Valenciano de Oncología, Valencia, Spain

    Amparo Quilis

  2. Hospital Universitario de Fuenlabrada, Madrid, Spain

    Jaime Martín

  3. Grupo IMO, Madrid, Spain

    Concepción Rodríguez

  4. Hospital Ruber Internacional, Madrid, Spain

    Purificación Sánchez

  5. Institut Català d’Oncologia – ICO, Barcelona, Spain

    Juan Luis Ribes

Authors
  1. Amparo Quilis
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  2. Jaime Martín
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  3. Concepción Rodríguez
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  4. Purificación Sánchez
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  5. Juan Luis Ribes
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Corresponding author

Correspondence to Amparo Quilis.

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Funding

The work was supported by Laboratorios LETI S.L.U. Dressings were supplied by Stratpharma AG, Switzerland free of charge.

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Quilis, A., Martín, J., Rodríguez, C. et al. Reducing radiation dermatitis during ongoing radiation therapy: an innovative film-forming wound dressing. J Radiat Oncol 7, 255–264 (2018). https://doi.org/10.1007/s13566-018-0356-5

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  • DOI: https://doi.org/10.1007/s13566-018-0356-5

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