BACKGROUND AND PURPOSE: The purpose of this study was to assess the effects of ultrasound (US) therapy in the treatment of pressure ulcers as an adjunct to standardized treatment. SUBJECTS:Eighty-eight patients from 11 nursing homes and one hospital participated. Subjects were randomly assigned to either a US group (n = 45) or a sham US group (n = 43). METHODS: This was a multicenter placebo-controlled randomized trial. Wound survival, healing rates of wound surfaces, and changes on a clinical rating scale were measured over 12 weeks. RESULTS: Comparison of the 12-week cumulative incidences of wound closure showed that 40% (18/45) of ulcers in the US group and 44% (19/43) of ulcers in the sham US group were closed. An analysis in which between-group baseline differences and the days of wound closures were accounted for showed that the wound closure probability per unit of time (ie, closure rate) was almost equal in the two treatment groups (Cox proportional-hazards ratio of 1.08). Mean absolute healing rates were 0.18 and 0.31 cm2/wk in the US and sham US groups, respectively. Relative healing rates and healing speeds were similar in the two treatment groups. A panel scored slides of the ulcers with a report mark between 1 (bad) and 10 (excellent). The improvement was 0.71 and 0.46 points per week in the US and sham US groups, respectively. CONCLUSION AND DISCUSSION: These data do not support the idea that US speeds up the healing of pressure ulcers.
RCT Entities:
BACKGROUND AND PURPOSE: The purpose of this study was to assess the effects of ultrasound (US) therapy in the treatment of pressure ulcers as an adjunct to standardized treatment. SUBJECTS: Eighty-eight patients from 11 nursing homes and one hospital participated. Subjects were randomly assigned to either a US group (n = 45) or a sham US group (n = 43). METHODS: This was a multicenter placebo-controlled randomized trial. Wound survival, healing rates of wound surfaces, and changes on a clinical rating scale were measured over 12 weeks. RESULTS: Comparison of the 12-week cumulative incidences of wound closure showed that 40% (18/45) of ulcers in the US group and 44% (19/43) of ulcers in the sham US group were closed. An analysis in which between-group baseline differences and the days of wound closures were accounted for showed that the wound closure probability per unit of time (ie, closure rate) was almost equal in the two treatment groups (Cox proportional-hazards ratio of 1.08). Mean absolute healing rates were 0.18 and 0.31 cm2/wk in the US and sham US groups, respectively. Relative healing rates and healing speeds were similar in the two treatment groups. A panel scored slides of the ulcers with a report mark between 1 (bad) and 10 (excellent). The improvement was 0.71 and 0.46 points per week in the US and sham US groups, respectively. CONCLUSION AND DISCUSSION: These data do not support the idea that US speeds up the healing of pressure ulcers.