A Randomized, Controlled Clinical Study to Assess the Effect of Anodal and Cathodal Electrical Stimulation on Periwound Skin Blood Flow and Pressure Ulcer Size Reduction in Persons with Neurological Injuries.

The use of electrical stimulation (ES) should be considered for treating nonhealing pressure ulcers (PUs), but optimal ES wound treatment protocols have yet to be established. A randomized, controlled, double-blind clinical study was conducted to evaluate the effects of cathodal and anodal high-voltage monophasic pulsed current (HVMPC) on periwound skin blood flow (PSBF) and size reduction of Stage 2 to Stage 4 PUs of at least 4 weeks' duration. Persons >18 years of age, hospitalized with neurological injuries, at high risk for PU development (Norton scale <14 points; Waterlow scale >15 points), and with at least 1 Stage 2 to Stage 4 PU were eligible to participate in the study. Persons with necrotic wounds, osteomyelitis, electronic or metal implants in the PU area, PUs in need of surgical intervention, acute wound inflammation, diabetes (HBA1c >7%), diabetic neuropathy, cancer, and/or allergies to standard wound treatments were excluded. Patients were randomly assigned to 1 of 3 groups: anodal (AG), cathodal (CG), or placebo (PG) ES. All groups received individualized PU prevention and standard wound care. In the PG, sham ES was applied; the AG and CG were treated with anodal and cathodal HVMPC, respectively (154 µs 100 Hz; 360 µC/second; 1.08 C/day), 50 minutes per day, 5 days per week, for a maximum of 8 weeks. PSBF was measured using laser Doppler flowmetry at baseline, week 2, and week 4, and wound surface area measurements were obtained and analyzed using a digitizer connected to a personal computer. Data analysis utilized the maximum-likelihood chi-squared test, the analysis of variance Kruskal-Wallis test, the Kruskal-Wallis post-hoc test, and Spearman's rank order correlation. Nonlinear approximation based on exponential function was used to calculate treatment time needed to reduce the wound area by 50%. In all tests, the level of significance was set at P ≤.05. Of the 61 participating patients, 20 were in the AG (mean age 53.2 ± 13.82 years), 21 in the CG (mean age 55.67 ± 17.83 years), and 20 in the PG (mean age 52.5 ± 13.18 years). PUs (baseline size range 1.01 cm2 to 59.57 cm2; duration 4 to 48 weeks) were most frequently located in the sacral region (73.77%) and classified as Stage 3 (62.29%). PSBF at week 2 was significantly higher in the AG and CG than in the PG (P <.05). Week 4 differences were not statistically significant. Wound percentage area reduction calculated at week 8 for the AG (64.10% ± 29.22%) and CG (74.06% ± 23.23%) were significantly different from PG ulcers (41.42% ± 27.88%; P = .0391 and P = .0024, respectively). In both ES groups, PSBF at week 4 and percent wound surface area reductions between weeks 4 and 8 were positively correlated, but only the AG correlation was statistically significant (P = .049). In this study, both ES modalities improved blood flow and wound area reduction rate. Studies examining optimal ES treatment times for healing to occur, the effect of comorbidities and baseline wound variables on ES outcomes, and the nature of the relationship between blood flow and healing are necessary.

The Efficacy of Pressure Ulcer Treatment With Cathodal and Cathodal-Anodal High-Voltage Monophasic Pulsed Current: A Prospective, Randomized, Controlled Clinical Trial.

BACKGROUND: Studies show that anode and cathode electrical stimulation (ES) promotes the healing of wounds, but specific protocols for both electrodes are not available. OBJECTIVE: To compare the effectiveness of cathodal versus cathodal+anodal ES in the treatment of Category II-IV pressure ulcers (PrUs). DESIGN: Prospective, randomized, controlled, clinical study. SETTING: Three nursing and care centers. PATIENTS: Sixty-three participants with PrUs were randomly formed into a cathodal ES group (CG: N = 23; mean age of 79.35; SD 8.48), a cathodal+anodal ES group (CAG: N = 20; mean age of 79.65; SD 11.44) and a placebo ES group (PG: N = 20; mean age of 76.75; SD 12.24). INTERVENTION: All patients were treated with standard wound care and high-voltage monophasic pulsed current (HVMPC; twin-peak impulses; 154 µs; 100 pps; 0.25 A; 250 µC/s) for 50 minutes per day, 5 times a week, for 6 weeks. The CG, CAG, and PG received, respectively, cathodal, cathodal+anodal, and sham ES through electrodes placed on a moist gauze pad. The treatment electrode was placed on the wound, and the return electrode was positioned on healthy skin at least 20 cm from the PrU. MEASUREMENTS: Measurements were made at baseline, and after each of the 6 weeks of treatment. Primary outcome was percentage wound surface area reduction at week 6. RESULTS: Wound surface area decreased in the CG by 82.34% (95% confidence interval [CI] 70.06-94.63) and in the CAG by 70.77% (95% CI 53.51-88.04). These reductions were significantly greater than in the PG (40.53%; 95% CI 23.60-57.46). The CG and CAG were not statistically significantly different regarding treatment results. LIMITATIONS: The time of treatment proved insufficient for PrUs to close. CONCLUSIONS: Cathodal and cathodal+anodal HVMPC similarly reduced the area of Category II-IV PrUs.