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New bandage may soothe radiation burns in breast cancer patients

NCT ID NCT07332754

Symptom relief Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a special dressing coated with a substance that binds bacteria (DACC-coated hydrogel) to treat skin burns caused by radiation therapy in 18 women with breast cancer. The goal was to see if it could reduce pain and help heal the skin. The study is already completed, but because it was small and looked back at past cases, the results are not definitive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DACC-coated hydrogel dressing
What this could lead to
If effective, this dressing could offer a simple way to ease pain from radiation skin burns in breast cancer patients.
What could go wrong
This was a very small (18 participants) retrospective study with no comparison group, so results may not be reliable or apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

18 people

The number who actually took part.

Started

Jan 2023

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm radiodermatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Radiodermatitis; acute

Contacts and locations

Locations

  • Irccs Ospedale Galeazzi Sant'Ambrogio

    Milan, Milano, 20157, Italy

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