the study aimed to evaluate the clinical effectiveness, safety and tolerability of a DACC-coated hydrogel advanced dressing for the treatment of radiodermatitis in patients undergoing radiotherapy for breast cancer.

The planned assessments include recording RTOG and NRS scores at time points T0 (starting treatment), T1, and T2 (end of treatment), documenting the time to complete re-epithelialization, any interruption of radiotherapy treatment, and collecting organizational and economic data for HTA and SWOT analyses.

Inclusion Criteria:

• Female sex

• Age ≥18 years

• Histologically confirmed diagnosis of breast cancer, undergoing adjuvant radiotherapy after surgery and/or chemotherapy.

• Onset of grade 2-3 radiodermatitis according to the RTOG scale, mainly located in the inframammary region, with or without axillary or supraclavicular extension.

• Patients treated with a DACC-coated hydrogel device following a radiodermatitis diagnosis, between January 2023 and October 2025.

• Treated on an outpatient basis with an advanced dressing protocol including:

  • Cleansing with 0.05% sodium hypochlorite solution
  • Application of DACC-coated hydrogel dressing, replaced every 2-3 days.

• Complete clinical data available in outpatient records, including NRS and RTOG.

Exclusion Criteria:

• Grade 0 radiodermatitis (absence of skin toxicity)
• Patients with incomplete clinical data or insufficient documentation for the purposes of retrospective analysis
• Lack of availability of minimum clinical follow-up until complete re-epithelialization

female

The study population includes adult female patients (≥18 years) with histologically confirmed breast cancer who underwent adjuvant radiotherapy at IRCCS Ospedale Galeazzi Sant'Ambrogio (Milan, Italy) between January 2023 and October 2025 and developed acute radiation dermatitis requiring treatment. Most patients presented with moderate to severe radiation dermatitis (RTOG grade 2-3), predominantly involving the inframammary region, with or without axillary or supraclavicular extension. A limited number of patients with grade 1 dermatitis were also included when clinically justified, in order to reflect real-world clinical practice. All patients were managed in an outpatient setting using a standardized protocol with a DACC-coated hydrogel dressing, and complete clinical documentation was available for retrospective analysis.

Not applicable. Individual participant data will not be shared, as this is a retrospective, single-center observational study based on routinely collected clinical data that are pseudonymized and subject to institutional and regulatory privacy restrictions.