Hydrofilm Polyurethane Films Reduce Radiation Dermatitis Severity in Hypofractionated Whole-Breast Irradiation: An Objective, Intra-Patient Randomized Dual-Center Assessment

Abstract

Radiation-induced skin injury represents the most frequent side effect in breast cancer patients undergoing whole-breast irradiation (WBI). Numerous clinical studies on systemic and topical treatments for radiation dermatitis have failed to provide sustainable treatment strategies. While protective skin products such as dressings are undoubtedly the standard of care in wound care management, their utilization as preventive treatment in radiotherapy has been somewhat neglected in recent years. In this prospective, intra-patient randomized observational study, Hydrofilm polyurethane films were prophylactically applied to either the medial or lateral breast-half of 74 patients with breast cancer undergoing hypofractionated whole-breast irradiation following breast-preserving surgery. Maximum radiation dermatitis severity was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 toxicity scores, photospectrometric erythema and pigmentation measurements and patient-assessed modified Radiation-Induced Skin Reaction Assessment Scale (RISRAS) scale. Phantom studies revealed a clinically negligible dose build-up of less than 0.1% with Hydrofilm. Compared to the control compartments physician-assessed radiation dermatitis severity was reduced in the hydrofilm compartments (mean 0.54 vs. 1.34; p = < 0.001). Objective photospectrometric skin measurements showed decreased erythema (p = 0.0001) and hyperpigmentation (p = 0.002) underneath Hydrofilm. Hydrofilm also completely prevented moist desquamation, and significantly reduced patients’ treatment-related symptoms of itching, burning, pain, and limitations of day-to-day-activities. Significant beneficial effects were observed in terms of radiation dermatitis severity, erythema, hyperpigmentation as well as subjective treatment-related symptom experiences, while adverse reactions were rare and minor. Therefore, a prophylactic application of Hydrofilm polyurethane films can be suggested in hypofractionated WBI.

Objective Evaluation of Risk Factors for Radiation Dermatitis in Whole-Breast Irradiation Using the Spectrophotometric L*a*b Color-Space

“…Along with objectivity, a continuous scale enumerating even slight changes in the skin color also allows us to draw precise conclusions on both the development of RID and the efficacy of specific treatments [ 2 , 5 , 11 , 22 , 23 ].…”

“…In light of the aforementioned and varying study results, this quintessence was not entirely unexpected. Many authors, therefore, concluded that future studies should endeavor to meet the requirement for a more objective approach in the RID evaluation process [ 5 , 6 , 16 , 17 ].…”

“…The identification and evaluation of specific risk factors for RID is imperative to anticipate RID severity and to adjust the therapy accordingly. These adjustments are based on both the avoidance and mitigation strategies for RID alike [ 2 , 5 , 6 ].…”

Selection of Appropriate Wound Dressing for Various Wounds

“…Radiation dermatitis severity was reduced in patients with breast cancer radiotherapy after prophylactic use of Hydrofilm (Paul Hartmann AG, Heidenheim, Germany) compared with control (Schmeel et al, 2019). A study examined the effect of a film dressing (Airwall) in the management of acute radiation dermatitis induced by proton beam therapy.…”

Alterações Dermatológicas Durante Tratamento Oncológico de Mulheres com Câncer de Mama: Estudo em Prontuários Clínicos

“…Considerando as mulheres diagnosticadas com câncer de mama, o tratamento radioterápico tem sido amplamente difundido, reduzindo as taxas de recorrência local após procedimentos cirúrgicos e/ou quimioterapia. Entretanto, a preocupação com as reações cutâneas adversas, associadas à radioterapia, tem sido constante, embora sejam bem toleradas pela maioria das pacientes 7,8 .…”