Retrospective Observational Study on the Use of Advanced Bacterial-binding Dressings (DACC-coated Hydrogel Dressings) in Radiodermatitis (RadioDACC)

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status: Completed

Conditions: Radiodermatitis; Acute

Study type: Observational

Funder types: Other

Identifiers

NCT07332754

RadioDACC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

18 participants in 1 patient group

Female patients undergoing adjuvant radiotherapy affected by radiodermatitis for breast cancer

Description:

Female patients treated with a DACC-coated hydrogel device following the diagnosis of grade 2-3 radiodermatitis according to the RTOG scale mainly localized in the inframammary region, with or without axillary or supraclavicular extension. Outpatient treatment with an advanced dressing protocol including: cleansing with 0.05% sodium hypochlorite solution, application of DACC-coated hydrogel dressing with replacement every 2-3 days.