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A randomized trial of low-air-loss beds for treatment of pressure ulcers |
Ferrell BA, Osterweil D, Christenson P |
JAMA 1993 Jan 27;269(4):494-497 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; 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* |
OBJECTIVE: To assess the effectiveness of low-air-loss beds for the treatment of pressure ulcers in nursing homes. DESIGN: Prospective, randomized, clinical trial. SETTING: Three teaching nursing homes in Los Angeles, Calif. SUBJECTS: Eighty-four nursing home residents with trunk or trochanter pressure ulcers (Shea stage >= 2). INTERVENTIONS: Subjects were randomly assigned to use either a low-air-loss bed (n = 43) or a 10-cm corrugated foam mattress (n = 41) throughout the healing of their ulcers. OUTCOME MEASURES: Ulcers were assessed twice weekly using surface area and two observational scales (median follow-up 37.5 days; range 4 to 571 days). RESULTS: Groups were similar with respect to demographics, medical variables, wound care, and early dropouts. Results indicate more than a threefold improvement in median rate of healing for low-air-loss beds compared with foam mattresses (9.0 versus 2.5 mm2/d; p = 0.0002). This finding was true for deep as well as superficial ulcers (deep ulcers 9.9 versus 0.7 mm2/d; p = 0.02; superficial ulcers 9.0 versus 3.2 mm2/d; p = 0.004). Cox regression models revealed that the bed, ulcer depth, and fecal continence had independent effects on healing. After controlling for fecal continence, the deep and superficial subgroups using low-air-loss beds remained 2.5 times more likely to heal in a given length of time compared with those using foam mattresses (combined cure probability ratio 2.66; 95% confidence interval 1.34 to 5.17; p < 0.004). CONCLUSION: Low-air-loss beds provide substantial improvement compared with foam mattresses despite other factors in pressure ulcer healing.
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