Clinical trial · Observational
Retrospective Observational Study on the Use of Advanced Bacterial-binding Dressings (DACC-coated Hydrogel Dressings) in Radiodermatitis
Retrospective Observational Study on the Use of Advanced Bacterial-binding Dressings (DACC-coated Hydrogel Dressings) in Radiodermatitis in Women Undergoing Radiotherapy for Breast Cancer
NCT07332754CI-TRIAL-00100588RadioDACCcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiodermatitis; Acute | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Female patients undergoing adjuvant radiotherapy affected by radiodermatitis for breast cancer
- description
- 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.
Primary outcomes (1)
- measure
- Evaluation of clinical effectiveness of the advanced DACC-coated hydrogel dressing
- timeFrame
- From enrollment to the end of treatment at T2 (clinical resolution/complete re-epithelialization within 20 days from the start of treatment (T0).
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.