Trials Sponsors Conditions Drugs Pricing

Conditions

Radiodermatitis; Acute

Keywords

radiodermatitisacute wound care treatmentDACC-coated hydrogel dressingradiotherapybreast 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

Age18 Years+

Sexfemale(Gender-based eligibility)

Gender Eligibility Detailsfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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:

Sponsors & Collaborators

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

Study Sites (1)

Irccs Ospedale Galeazzi Sant'Ambrogio

Milan, Milano, 20157, Italy

MeSH Terms

Conditions

RadiodermatitisBreast Neoplasms

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesRadiation InjuriesWounds and InjuriesNeoplasms by SiteNeoplasmsBreast Diseases

Enrollment

18 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Female patients undergoing adjuvant radiotherapy affected by radiodermatitis for breast cancer

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Female patients undergoing adjuvant radiotherapy affected by radiodermatitis for breast cancer

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations