Objective: Data show that heel protectors markedly reduce vertical pressure thus preventing heel ulceration. We, therefore, determined the risks associated with the development of heel ulceration and tested the benefits of several heel protection methods (boot, waffle, suspension boot, pillow, or standard protocol) in reducing heel pressure and the development of heel ulcers. Design: A randomized open-label repeated measures design was used to compare the treatment-effects of five interventions to prevent heel ulcers. Subjects were recruited for participation in the first 24 hours following hospitalization and evaluated for at least 48 hours. Population, Sample, Setting, Years: Forty subjects (mean age 74.3 ± 14.2 years), who were admitted to medical service in an academic medical center at risk for heel pressure ulcers (Braden Scale scores of <14), were randomly assigned to one of five preventative treatments. Subjects were only considered for participation if they were confined to a wheelchair or bed on admission. The study was initiated in February 2000 and ended October 2001. Concept or Variables Studied Together or Interventions and Outcome Measures: A clinically significant number of patients develop hospital-acquired heel pressure ulcers, yet there is little known about the effects of heel protection methods in preventing their occurrence or minimizing severity. Information on age, weight and primary and secondary diagnoses was collected for each subject. Heel protection methods studied included the boot, waffle, suspension boot, pillow, and standard protocol. The Braden Scale was used to determine the risk for skin breakdown. The degree of heel ulceration was quantified using the National Advisory Pressure Ulcer Staging Classification. We recorded the number of hours that each heel protectors was in place and the reasons why the protectors were removed for each 24-hour period. Methods: Acceptable interrater reliability was established for the Ulcer Staging Classification prior to the initiation of the study among all data collectors, who were expert wound care specialists. Nurses participating in the study were instructed on the proper placement and removal of all heel prevention devices. Initial baseline Braden Scale scores and Ulcer Staging ratings were obtained on all subjects. Daily assessments of skin breakdown were performed. We recorded the number of hours heel protectors were in place each day. Findings: There were no statistically significant differences between groups for age, weight and baseline Braden Scale scores. Only two of twenty-six subjects developed a Stage 1 ulcer by day 2. No statistically significant between-group differences in Braden Scale scores were noted over time, indicating subjects’ risks for heel ulceration remained similar throughout the study. The average number of hours that the heel protectors were in place did not differ between groups for both day 1 or 2. The most common reason for removing the heel protectors included getting out of bed, being uncomfortable, refusal to wear the device, and pain. Conclusions: We conclude that all methods were effective in preventing the occurrence of heel pressure ulcers for patients with similar risk factors (e.g., age, weight and Braden Scale scores). Implications: Our findings have significant implications for designing studies and methodologies to evaluate heel ulcer prevention methods. Sample calculations for detecting differences in methods to prevent heel ulcers should be based on the assumption that there is likely to be a small treatment-effect, therefore, larger sample sizes should be considered. In order to establish efficacy for heel ulcer prevention methods, it may be necessary to include only those patients on strict bedrest and extend the study beyond 72 hours. It appears, however, that regardless of what device or method is used, heel elevation is critical to reduce the occurrence of pressure-induced heel ulcers.
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