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

NCT ID: NCT07332754

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Radiodermatitis; Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Irccs Ospedale Galeazzi Sant'Ambrogio

Milan, Milano, Italy

Site Status

Countries

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Italy

Other Identifiers

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RadioDACC

Identifier Type: -

Identifier Source: org_study_id

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