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

Retrospective Observational Study on the Use of Advanced Bacterial-binding Dressings (DACC-coated Hydrogel Dressings) in Radiodermatitis in Women Undergoing Radiotherapy for Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Radiodermatitis; Acute

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.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Italy
  • Milano
    • Milan, Milano, Italy, 20157
      • IRCCS Ospedale Galeazzi Sant'Ambrogio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Female patients undergoing adjuvant radiotherapy affected by radiodermatitis for breast cancer; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of clinical effectiveness of the advanced DACC-coated hydrogel dressing	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).	From enrollment to the end of treatment at T2 (clinical resolution/complete re-epithelialization within 20 days from the start of treatment (T0).

Collaborators and Investigators

• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: breast cancer; radiotherapy; radiodermatitis; acute wound care treatment; DACC-coated hydrogel dressing
• Additional Relevant MeSH Terms: Wounds and Injuries; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Radiation Injuries; Dermatitis; Skin and Connective Tissue Diseases; Breast Neoplasms; Radiodermatitis
• Other Study ID Numbers: RadioDACC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No