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A prospective, randomized, controlled, clinical study to evaluate the efficacy of high-frequency ultrasound in the treatment of stage II and stage III pressure ulcers in geriatric patients
Polak A, Franek A, Blaszczak E, Nawrat-Szoltysik A, Taradaj J, Wiercigroch L, Dolibog P, Stania M, Juras G
Ostomy/Wound Management 2014 Aug;60(8):16-28
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

International guidelines recommend high-frequency ultrasound (HFUS; MHz) for treating infected pressure ulcers (PUs). A 2-year, prospective, randomized, controlled study was conducted to evaluate how HFUS affects PU healing among 42 geriatric patients treated in four nursing and care centers in Silesia, Poland. Participants (age range 71 to 95 years), all with wounds that did not respond to previous treatment for at least 4 weeks, were randomly assigned to the treatment group (TG) (20 with 21 PUs, mean age 83.60 +/- 5.04 years) or control group (CG) (22 with 23 PUs, mean age 82.59 +/- 6.65 years). All patients received standard wound care (SWC); the TG additionally was provided HFUS (1 MHz, 0.5 W/cm2, duty cycle of 20%, 1 to 3 minutes/cm2; one session per day, 5 days a week). Patients were monitored for 6 weeks or until wounds closed. Percent change in wound surface area (WSA), the Gilman's parameter, the weekly rate of change in WSA, and the percentage of PUs that improved (ie, decreased in size by at least 50% or closed) were used to compare differences. Data were analyzed using Fisher's exact test, the Wilcoxon matched pairs test, and the Mann-Whitney U test (p < 0.05). Mean baseline WSA and the pretreatment duration of PUs were 15.38 +/- 12.92 cm2 and 1.64 +/- 0.73 months and 11.08 +/- 7.52 cm2 and 2.26 +/- 1.42 months in the TG and CG groups, respectively. After 6 weeks of treatment, the WSA of PUs decreased significantly in both groups (p = 0.000069 in the TG and p = 0.0062 in the CG) with significantly greater improvement in the TG (an average of 68.80% +/- 37.23% compared with 37.24% +/- 57.84%; p = 0.047). The value of the Gilman's parameter was greater in the TG than in the CG (0.88 +/- 0.62 and 0.43 +/- 0.50, respectively; p = 0.018). The mean weekly change of WSA was greater in the TG than in the CG but only for stage II PUs (3.09 +/- 2.93 cm2/week and 1.08 +/- 1.43 cm2/week; p = 0.045). More stage II PUs in the TG decreased by at least 50% (11 of 14 = 78.57%) than in the CG (seven of 18 = 38.89%) (p = 0.035). In the TG, seven of 14 (50%) stage II PUs closed, four of seven (42.86%) stage III PUs decreased by at least 50%, and one of seven (14.29%) stage III PUs closed; respective values for the CG are three of 18 (16.67%), three of five (60%,) and zero of five (0%) (p = 0.062, p = 0.999, p = 0.999, respectively). The study showed HFUS therapy can reduce the WSA of PUs regardless of their shape, but further research is necessary, particularly to establish how ultrasound influences the healing of stage III and stage IV PUs.

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