Skip to main content
OpenTrials
Completed

NCT Number: NCT07332754

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Radiodermatitis; Acute Breast Diseases Breast Neoplasms Dermatitis Neoplasms Neoplasms by Site Radiation Injuries Radiodermatitis Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Irccs Ospedale Galeazzi Sant'Ambrogio

Milan, Milano, 20157, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluation of clinical effectiveness of the advanced DACC-coated hydrogel dressing

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: RadioDACC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.