Clinical trial NCT02925741: Silk-Like Bed Linens for Prevention of Unit-Acquired Ulcers
Official title: Clinical Trial of Silk-Like Linens for Prevention of Unit-Acquired Pressure Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: bed linens
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Standard Textile
name: Precision Fabrics Group, Inc.
First posted: 2016-10-06
Enrollment: 3343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Of 5 Medical ICUs at 1 quaternary care medical center, patients were assigned to groups based on bed availability by personnel who were blinded to linens used on those units.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Development of Unit-acquired Pressure Ulcers
timeFrame: During MICU admission
Secondary outcomes:
measure: The Time to Develop the First Unit-acquired Pressure Ulcer
timeFrame: Days from admission to HAPI
measure: Maximum Severity of Unit Acquired Pressure Injury (UAPI)
timeFrame: During MICU admission
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Mary Montague, MSN
role: PRINCIPAL_INVESTIGATOR
References: