None listed
Conditions
Brief summary
Breast cancer is the most common malignancy for women in New Zealand; most will receive radiation therapy treatment. Skin reactions occur in 80-90% of patients and these can vary from redness to blistering or peeling (ulceration). To date, there is no standard treatment for radiation-induced skin reactions. In a previous pilot study involving 30 women treated with radiation for breast cancer, we showed that Mepilex Lite dressings (a new Swedish silicon-foam skin dressing) were superior to a standard aqueous cream in decreasing redness of the skin. This current trial aims to investigate the effect of the dressings on ulceration in 80 women undergoing radiation treatment for breast cancer after mastectomy in public hospitals in Dunedin, Palmerston North, Wellington and in the Auckland Radiation Oncology private Centre. As soon as the skin turns red, the affected skin area will be randomly divided into two similar halves; one half will be covered in dressings, the other half will be treated with standard moisturising cream. Skin condition will be assessed three times a week for the duration of treatment, as well as once a week after treatment until complete resolution of the skin reactions, using an established skin assessment scale (RISRAS). (ACTRN12608000180314)
Interventions
Mepilex Lite dressings. These consist of a thin flexible foam layer with silicon webbing which does not react with chemicals in and on the skin. The silicon layer allows the dressings to adhere to healthy skin but not to open wounds. As soon as the skin shows signs of erythema, the red skin will be divided into two equal halves. The halves will be randomized to either Mepilex Lite or control cream by the PI Dr Patries Herst who has no direct invovement in the day to day running of the trial (bas
Mepilex Lite dressings. These consist of a thin flexible foam layer with silicon webbing which does not react with chemicals in and on the skin. The silicon layer allows the dressings to adhere to healthy skin but not to open wounds. As soon as the skin shows signs of erythema, the red skin will be divided into two equal halves. The halves will be randomized to either Mepilex Lite or control cream by the PI Dr Patries Herst who has no direct invovement in the day to day running of the trial (based on computer-generated random numbers). The dressings are applied to one half of the red skin (they adhere without the need for adhesives). Their position on the skin is indicated by black permanent marker pens. The dressings are removed for radiation treatment and during showering. careful instruction is given to patients how to handle the dressings to keep them in a clean place and how to reapply them after showering. The dressings are changed every 4 days but when moist desquamation occurs, they will be replaced daily. Dressings will be used until the skin reaction is completely resolved, which may be upt o 6 weeks after completion of radiation treatment.
Sponsors
Molnlycke Healthcare LTD
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All women receiving post-mastectomy radiation therapy for breast cancer.
Exclusion criteria
Women with previous RT or systemic disease are excluded. Women who are unable to come back to the department for more skin assessments once a week after treatment has been completed until the final check-up at 6 weeks are also excluded.
Outcome results
None listed