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Study aim
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The efficacy and safety of atmospheric pressure plasma versus low-level laser therapy on chronic wounds (including dystrophic epidermolysis bullosa)
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Design
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In this clinical trial, 6 patients with Dystrophic EB will be included and in each patient 5 wounds will be randomly selected for different kinds of treatment. In each patient, 2 wounds will be treated with plasma, 2 wounds with low level laser and one was dressed with standard wound care as the control.
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Settings and conduct
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The quality of wound healing will be assessed by evaluation of wound size and also a designed qualitative wound score (QWS), which evaluate the healing by scoring changes in four parameters as follows: (i) size (scores of 0, 1, and 2, indicating decreased size, no change or increased size, respectively); (ii) odour (0, no and 1, yes); (iii) exudate (scores of 0, 1 and 2 indicating none, mild and moderate to severe, respectively); and (iv) redness (scores of 0, 1 and 2 indicating none, pink and red, respectively). A dermatologist who is unaware of the assigned treatment for each lesion, recruit to assess the lesions before treatment, after each session of treatment (during treatment), 2, 6 and 12 weeks after treatment
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Participants/Inclusion and exclusion criteria
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- Inclusion criteria: Dystrophic EB patients with age over 10 years, old chronic wounds over 3 months, Full satisfaction for entrance to the study, without exclusion criteria
- Exclusion criteria: Other comorbidities including collagen vascular diseases and vasculitis, coronary artery diseases, active infection, malignancy on the treatment area, Alcoholics and smokers
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Intervention groups
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Dystrophic EB patients who have old chronic wounds over 3 months with no response to conventional treatments
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Main outcome variables
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Time of complete wound healing
Dermatology Life Quality Index
Qualitative wound score (QWS)
Recurrence time