2.1 The MIST Therapy system (Celleration) aims to promote wound healing in chronic, 'hard-to-heal' wounds and acute wounds by delivering low-energy, low-intensity ultrasound to the wound bed through a continuous saline mist. The mist is claimed to transmit the ultrasonic energy to the wound bed, to activate healing by the removal of slough, exudate and bacteria, and to stimulate tissue regeneration.
2.2 The MIST Therapy system comprises a generator, a single-use applicator and a sterile saline bottle. Wound surface area is measured and entered into the MIST Therapy system, which then calculates the appropriate treatment time. When the applicator and saline bottle are connected, the ultrasound system is activated and a continuous mist is delivered to the wound bed using a hand-held applicator. The distance between the applicator and the wound bed is 0.5–1.5 cm. Once the treatment is complete, the generator switches off automatically.
2.3 The MIST Therapy system is intended for use as an adjunct to standard wound care with dressings and other cleaning or debridement as necessary.
2.4 Each treatment is estimated to take 5–7 minutes to complete and is normally performed three times a week, at the same treatment session as the wound dressings are changed.
2.5 The annual rental price of the MIST Therapy system stated in the manufacturer's submission is £7500.
2.6 Standard care for chronic, 'hard-to-heal' wounds normally involves the use of advanced wound dressings, which include: alginate, capillary action, charcoal, foam, honey, hydrocolloid, hydrocolloid fibrous, hydrogel, iodine, low- or non-adherent wound contact layer, silicone and silver dressings. Venous leg ulcers are a common type of chronic wound and compression bandaging is a mainstay of treatment, provided that serious ischaemia is not present.
2.7 Standard practice in the management of chronic wounds also includes wound debridement to remove dead tissue, and systemic antibiotic therapy for patients with wounds showing clinical signs of infection.