Radiodermatitis; Acute
Conditions
Keywords
radiodermatitis, acute wound care treatment, DACC-coated hydrogel dressing, radiotherapy, breast cancer
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of clinical effectiveness of the advanced DACC-coated hydrogel dressing | From enrollment to the end of treatment at T2 (clinical resolution/complete re-epithelialization within 20 days from the start of treatment (T0). | Evaluate the clinical effectiveness of the advanced DACC-coated hydrogel dressing used in the management of severe radiodermatitis in patients undergoing radiotherapy for breast cancer; effectiveness will be measured by assessing the reduction in pain using the NRS at the beginning and end of the treatment (from T0 to T2). |
Countries
Italy
Outcome results
None listed