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

Not Applicable

Completed

Conditions: Pressure Ulcer

Interventions: Other: Silk-Like Linens

Registration Number: NCT02925741

Lead Sponsor: The Cleveland Clinic

Brief Summary: This study will use a traditional parallel randomization 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). 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. Bed linens will be changed per unit protocol. Patient characteristics will be summarized using frequencies and percentages for categorical factors and means, standard deviations, percentiles and median and range for continuous measures. 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. 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

Detailed Description: 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 parallel randomized 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). Patients were randomly assigned by personnel who were blinded to the intervention based on bed availability. Nurses will assess all patients on standard bed linens and silk-like linens for development of UAPU. 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3343

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silk-Like Linens	Silk-Like Linens	Patients in the experimental arm will be cared for on silk-like bed linens.

Primary Outcome Measures

Name	Time	Method
Rate of Development of Unit-acquired Pressure Ulcers	During MICU admission	Total count of the number of patients who developed unit acquired pressure ulcers during the study (count)

Secondary Outcome Measures

Name	Time	Method
The Time to Develop the First Unit-acquired Pressure Ulcer	Days from admission to HAPI	The number of days spent in the intensive care unit prior to the development of a pressure ulcer
Maximum Severity of Unit Acquired Pressure Injury (UAPI)	During MICU admission	HAPI staged by trained clinical nurses using the National Pressure Advisory Panel (NPUAP) staging definitions in which Stage 1 is the least severe with severity progressing through Stage 2, 3, 4, and unstageable. Unstageable is an evolving type of pressure injury evolving into a Stage 3 or 4.