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

NCT07332754 | Completed

• 1 other identifier: RadioDACC
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiodermatitis; Acute

Keywords

radiodermatitis; acute wound care treatment; DACC-coated hydrogel dressing; radiotherapy; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Irccs Ospedale Galeazzi Sant'Ambrogio

Milan, Milano, 20157, Italy

Location

MeSH Terms

Conditions

Radiodermatitis; Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)