Clinical trial · Interventional
The Use of Silver Leaf Dressing in the Prevention of Radiotherapy Induced Skin Reactions
A Phase III Study of the Efficacy of Silver Leaf Nylon Dressing in the Prevention of Severe Skin Reactions in the Inframammary Skin Fold of Patients Receiving Adjuvant Whole Breast Radiotherapy
- 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 hypothesis is that silver leaf nylon dressing reduces the percentage of patients developing brisk erythema and moist desquamation while undergoing whole breast radiotherapy. The secondary hypothesis is that silver leaf nylon dressing reduces breast-related symptoms of pain, itching and burning sensation in patients receiving whole breast radiotherapy.
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 |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Silver Leaf Dressing | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- silver leaf nylon dressing reduces the percentage of patients developing brisk erythema and moist desquamation while undergoing whole breast radiotherapy
Secondary outcomes (1)
- measure
- silver leaf nylon dressing reduces breast-related symptoms of pain, itching and burning sensation in patients receiving whole breast radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Women diagnosed with completely excised stage I or II invasive breast cancer, or DCIS, who have undergone breast-conserving surgery and are scheduled to undergo adjuvant breast radiotherapy will be eligible for this study if they are at increased risk of radiodermatitis at the inframammary fold due to breast size or shape (i.e at least 2cm of skin apposition at the inframammary fold, and/or brassiere cup size C or greater). 2. Patients undergoing nodal radiotherapy are eligible if criterion 1 is met 3. Patients undergoing boost radiotherapy are eligible if criterion 1 is met, but only if the boost volume does not include any part of the breast inferior to the nipple line 4. Patients may be entered into other local or national trials unless these involve an alteration to standard skin care or altered breast radiotherapy technique Exclusion Criteria: * inability to give informed consent * inability to comply with experimental arm of trial * failure of healing of the surgical scar or significant post-operative infection of the wound * prior radiotherapy to either breast or to the chest * presence of significant connective tissue disease (e.g. systemic sclerosis, systemic lupus erythematosis) * known radiation hypersensitivity phenotype (e.g. ataxia telangiectasia etc) * inability to return for assessment at one week following completion of radiotherapy * allergy to silver
References
Publications (0)
Data not yet available