Silk-Like Bed Linens for Prevention of Unit-Acquired Ulcers

Although there has been a large amount of research published on contributing factors to
pressure ulcers, there has been little research related to the role that bed linens play in
affecting moisture, friction, and shear that may lead to development of unit-acquired
pressure ulcers (UAPU) for patients in acute care settings. This study will use a traditional
cluster randomized crossover design with patients in five medical intensive care units at the
Cleveland Clinic to evaluate the efficacy of silk-like bed sheets and underpads for
prevention of Unit-Acquired Pressure Ulcers (UAPU). Nurses will assess all patients on the
units for three months on the standard bed linens and three months on the silk-like linens.
For each unit, the order of intervention will be randomized. Adult hospitalized patients in
beds with standard bed linens versus those with silk-like linens will be compared for 1) rate
of development of UAPU, 2) time to develop the first UAPU, and the maximum severity of any
UAPU that develop. Upon entry into the study, all patients will be assessed for baseline skin
integrity by the admitting nurse. Demographic data (MRN; unit name; type of linen on bed;
admitting diagnosis; dates of admission/discharge; age; gender; race; weight; Braden score;
date, location, and stages of UAPU development; lab values (albumin, total protein); and
categories of the Charlson Comorbidity Index will be recorded on data collection form by
research nurse. Bed linens will be changed per unit protocol. A sample size of 3456 patients
is estimated. Patient characteristics will be summarized using frequencies and percentages
for categorical factors and means, standard deviations, percentiles and median and range for
continuous measures. Comparisons of these patient characteristics, including Braden score,
Charlson comorbidity index, unit length of stay and hospital length of stay, will be compared
between linen types using generalized linear mixed effect models. For the primary outcome of
unit-acquired pressure ulcer rate, generalized linear mixed models, assuming a Poisson
distribution for the outcome, and unit length of stay as an offset will be used. In these
models, linen type and study period will be used as fixed effects and each unit will be
included as a random effect. For the time to event analysis, frailty models will be used to
assess whether time to first pressure ulcer differs between treatment types. Generalized
linear mixed models will be used for other secondary endpoints, including maximum severity of
observed pressure ulcers.

Inclusion Criteria:

- All patients admitted into the medical intensive care unit during the one year study
period

Exclusion Criteria:

- Patients who are transferred from one study unit to another study unit, data for their
days on the second unit will be measured only if the second unit is in the same study
arm as the sending unit

- Patients who are proned

- Patients remaining on a unit past the two week washout period, will not be included in
the crossover arm