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

Pressure Ulcer Clinical Trial

Official title:

Clinical Trial of Silk-Like Linens for Prevention of Unit-Acquired Pressure Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925741
• Other study ID #: 13-752
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: July 2020
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 3343
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Other:
• Silk-Like Linens
Synthetic moisture-wicking fabric

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
The Cleveland Clinic	Precision Fabrics Group, Inc., Standard Textile

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Development of Unit-acquired Pressure Ulcers	Total count of the number of patients who developed unit acquired pressure ulcers during the study (count)	During MICU admission
Secondary	The Time to Develop the First Unit-acquired Pressure Ulcer	The number of days spent in the intensive care unit prior to the development of a pressure ulcer	Days from admission to HAPI
Secondary	Maximum Severity of Unit Acquired Pressure Injury (UAPI)	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.	During MICU admission