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Healing of advanced pressure ulcers by a generic total contact seat: 2 randomized comparisons with low air loss bed treatments
Rosenthal MJ, Felton RM, Nastasi AE, Naliboff BD, Harker J, Navach JH
Archives of Physical Medicine and Rehabilitation 2003 Dec;84(12):1733-1742
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*

DESIGN: Randomized prospective cohort study. SETTING: Long-term care facilities. PARTICIPANTS: Two hundred seven subjects with stage III or IV pressure ulcers. INTERVENTION: Two separate randomized control studies of advanced pressure ulcers that compared wound healing on 3 different support surfaces. Subjects were allocated to low air loss bed, upgraded bed overlay (only in study 1), or 4 h/d sitting on an experimental generic total contact seat. The seat was designed using prosthetics principles aimed at distributing pressure off bony prominences onto less pressure-sensitive areas. Subjects were followed for 6 months or until they were totally healed. MAIN OUTCOME MEASURES: Number of subjects who totally healed, time to total healing, and pressure ulcer status score after 4 weeks of treatment. Interface pressures and functional capacity were also measured at 4 weeks. RESULTS: In study 1, 3 subjects worsened on the bed overlay condition and were withdrawn from the study. None worsened on low air loss or generic total contact seat. At 4 weeks in both studies, pressure ulcer status score was lowest for the generic total contact seat (p < 0.0001), compared with the other surfaces. Subject populations were similar, so to analyze total healing, results from both studies were combined. Total healing of pressure ulcers occurred as early as 4 weeks in some subjects using the generic total contact seat. Even at 8 weeks, total healing was primarily seen with use of that seat, on which interface pressures, function, and seating tolerance were best. CONCLUSIONS: Faster healing and better function indicate that treatment using the generic total contact seat is superior to low air loss bed therapy, which is standard care for advanced pressure ulcers.

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