Rg. Bennett et al., LOW AIRLESS HYDROTHERAPY VERSUS STANDARD CARE FOR INCONTINENT HOSPITALIZED-PATIENTS, Journal of the American Geriatrics Society, 46(5), 1998, pp. 569-576
OBJECTIVE: To determine whether low airless hydrotherapy reduces the i
ncidence of new skin lesions associated with incontinence in hospitali
zed patients and results in more rapid healing of existing pressure so
res compared with standard care. To assess subjectively patient and nu
rsing satisfaction related to using low airless hydrotherapy beds. DES
IGN: Randomized, prospective, unblinded study. SETTING: Acute and chro
nic hospital wards. PARTICIPANTS: A total of 116 newly admitted, incon
tinent, hospitalized patients with and without existing pressure sores
. INTERVENTION: Low airless hydrotherapy compared with treatment on ho
spital beds and mattresses ordered by the patient's attending physicia
n. MEASUREMENTS: Incidence rates of new skin lesion development, e.g.,
pressure sores, candidiasis, and chemical irritation; improvement in
existing pressure sore size, volume, and status; subjective assessment
of patient and nursing satisfaction. RESULTS: Possible hypothermia wa
s identified in two patients during the first week of the study, and p
atient and nursing dissatisfaction with low airless hydrotherapy remai
ned high throughout the first months of the study. Therefore, two majo
r modifications in the initial protocol were made: (1) increased patie
nt temperature monitoring for hypothermia was initiated in Week 2 of t
he study and (2) increased staff resources for in-service training on
bed use began in Week 18 of the study. After the latter change, 58 sub
jects were randomized to low airless hydrotherapy and 58 to standard c
are. Subjects were old (median age greater than or equal to 80 years),
and almost all were bedbound or nonambulatory. The median (range) len
gth of follow-up for subjects in the treatment group was significantly
shorter than for those in the control group (4 (1-60) days versus 6 (
1-62) days, respectively, P = .017) because there were more dropouts f
rom the treatment group (24 (36%) of 58 versus 2 (3%) of 58, P = .0001
). The major reasons dropout occurred were patient or family dissatisf
action (12 (21%)), new or worsened skin lesions thought to be related
to bed use (4 (7%)), and hypothermia < 97 degrees F (4 (7%)). The tota
l cumulative incidence of new truncal skin lesions within 9 days of en
rollment was greater in the treatment than in the control group (48% v
ersus 14%, respectively, P < 0.01). Too few patients with existing pre
ssure sores were treated for too short a period of time to assess the
effect df low airless hydrotherapy on pressure sore healing. Because o
nly 10 patients treated on low airless hydrotherapy beds were able to
complete satisfaction surveys meaningfully, interpretation of these da
ta is difficult. Only nine (21%) of 44 nurses subjectively reported ov
erall satisfaction using the low airless hydrotherapy bed. CONCLUSIONS
: This study shows the value of a rigorously designed clinically based
evaluation of a new product developed for older patients. The results
of the study led to re-engineering of the prototype low airless hydro
therapy bed as well as a change in marketing strategy. Studies of prod
ucts targeted to the prevention and treatment of pressure sores in old
er patients should be undertaken before generalized marketing begins.