Radiodermatitis; AcuteRadioDACCNCT07332754
Retrospective Observational Study on the Use of Advanced Bacterial-binding Dressings (DACC-coated Hydrogel Dressings) in Radiodermatitis
An observational study of Radiodermatitis; Acute, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiodermatitis; Acute
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Radiodermatitis; Acute
- Keywords
- radiodermatitis, acute wound care treatment, DACC-coated hydrogel dressing, radiotherapy, breast cancer
- Medical subject headings
- Radiodermatitis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment at T2 (clinical resolution/complete re-epithelialization within 20 days from the start of treatment (T0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jan 2023
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiodermatitis; AcuteStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332754
- Sponsor's protocol ID
- RadioDACC
- Acronym
- RadioDACC
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07332754
- Acronym / sponsor ID
- RadioDACC / RadioDACC
- Conditions
- Radiodermatitis; Acute
- Keywords
- radiodermatitis, acute wound care treatment, DACC-coated hydrogel dressing, radiotherapy, breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiodermatitis; Acute, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.