None listed
Conditions
Brief summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease which significantly affects the quality of life of affected patient. This is also a negative impact of the well-being of caregivers and financial burden. The main aims of treatment are to maintain skin barrier function, prevent flare-up and early treatment of symptoms which usually includes daily use of emollients with or without topical corticosteroids. Patients with moderate to severe AD may require wet wrap therapy (WWT) which has proven to be effective. However, the application process is tedious and requires multiple layers which may reduce compliance and unsuitable for tropical climate. The low durability of wet wraps also incurred significant financial costs to the patients. Customised nanotextile garment has been developed for this study. This garment has cooling properties, antibacterial properties to reduce bacterial infection and colonization, ultra-violet protection, breathable and long lasting which is suitable for use in tropical climate and more cost-effective for long-term therapy. 126 patients including 63 children and 63 adults, with moderate to severe atopic dermatitis will be recruited from the dermatology clinic and inpatient ward. They will be randomised into 2 arms with the study group using daily emollients with topical corticosteroids and nanotextile garments for WWT. The control group will use conventional Tubifast garments for WWT . Patient will be assessed before treatment, at 1 week and 2 weeks after treatment. Photo of lesion will be taken to assess eczema severity using SCORing Atopic Dermatitis (SCORAD) index and also check for any skin infection. Assessment of quality of life will be conducted using Infant Dermatitis Quality of Life and Children’s Dermatology Quality of Life Index for children, Dermatology Quality of life index for adults. Patient survey will also be conducted regarding comfort, convenience etc. to collect patients’ subjective feedback. We hypothesized that customised nanotextile garment is an effective adjunctive treatment for patients with moderate to severe atopic dermatitis. Primary objective is the improvement in clinical condition of the atopic dermatitis and quality of life after 2 weeks therapy for wet wrap therapy using customized nanotextile garments, which is non-inferior compared to conventional Tubifast garment WWT. Secondary objectives include improvement in compliance and infection rate, better patient feedback in terms of comfort and convenience compared to Tubifast garment WWT.
Interventions
Intervention: wet wrap therapy with wet wrap garment made of 100% nanopolyester. One garment set consists of a long sleeved shirt and a long pant, which covers the whole body except for head, neck, hands and feet. It comes with sizes for 6-24 month old, 2-5 year old, 5-8 year old, 8-11 year old, 11-14 year old, M size, L size, XL size and XXL size. A photo of patient wearing wet wrap therapy garment (Tubifast garment) can be found in attachment.
Participants will be recruited and issued with th
Intervention: wet wrap therapy with wet wrap garment made of 100% nanopolyester. One garment set consists of a long sleeved shirt and a long pant, which covers the whole body except for head, neck, hands and feet. It comes with sizes for 6-24 month old, 2-5 year old, 5-8 year old, 8-11 year old, 11-14 year old, M size, L size, XL size and XXL size. A photo of patient wearing wet wrap therapy garment (Tubifast garment) can be found in attachment. Participants will be recruited and issued with the wet wrap garment in dermatology clinic. Dermatology nurses will educate patients on the procedure of wet wrap therapy and instruct them to wear wet wrap garment overnight (4-8 hours) daily at home for 2 weeks. Garment wearing procedure: 1. Soak wet wrap garment in lukewarm water, gently squeeze until not dripping. 2. After bathing patient, gently pat patient skin dry with towel. 3. Apply moisturizer and topical steroids as prescribed by doctor. 4. Dress patient in one layer of damp wet wrap garment. 5. Apply a dry layer of cloth on top of the wet wrap garment. Patient will be reviewed on day 7 and day 14 of treatment in clinic and their adherence will be monitored and reminded during the visit.
Sponsors
Ang Seng Bin
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 90 Years
Healthy volunteers
No
Inclusion criteria
- outpatient or inpatient patients - with moderate-to-severe atopic dermatitis (SCORAD index >= 25)
Exclusion criteria
- patients with mild atopic dermatitis (SCORAD index <25) - patients currently on wet wrap therapy - patients on immunotherapy or phototherapy treatment
Outcome results
None listed