NICE opens consultation on MIST Therapy system for wound healing
MedWire News: The National Institute of Health and Clinical Excellence (NICE) in the UK has opened a consultation on whether to recommend the MIST Therapy (Celleration, Eden Prairie, Minnesota, USA) system for the treatment of chronic, 'hard-to-heal' wounds such as venous leg ulcers.
The system delivers low-energy, low-intensity ultrasound to the base of a wound through a continuous saline mist. The manufacturers claim that this therapy activates wound healing by removing slough, exudate, and bacteria,, while stimulating tissue regeneration.
MIST Therapy sessions take between 5 and 7 minutes to complete and should be performed during the changing of wound dressings, ie, usually three times a week.
Of 200 reports submitted by the manufacturers, 10 were considered to have provided the best clinical evidence by external assessors. These included reports from two randomized trials and eight observational studies.
The two randomized trials included 70 and 133 individuals with non-healing wounds and chronic critical limb ischemia or diabetic foot ulcers. Half of the patients in each trial were randomly assigned to receive MIST Therapy and half to standard wound care or placebo (sham device).
In the first study, significantly more patients in the MIST Therapy group than the standard care group had greater than 50% healing at 12 weeks, at 63% versus 29%. In the second study, the between-group difference in healing was nonsignificant at 10 weeks, with 18% versus 14% of MIST and placebo group patients experiencing greater than 50% healing.
The eight observational studies mostly demonstrated a significant benefit in wound healing for patients given MIST Therapy compared with those given standard care or an alternative control therapy such as a sham device.
If given approval, the MIST Therapy device could offer significant advantages both to patients and the National Health Service.
The NICE committee concluded that the MIST Therapy system shows great promise, but despite being supported by expert opinion, they decided that there is not currently enough high-quality evidence to make a positive recommendation for its use at present.
They accepted that the area of wound care in general lacks such evidence, but said that they would like to see further research on the use of this device for the healing of chronic wounds compared with standard care.
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By Helen Albert