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

NCT ID: NCT02925741

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3343 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-03-31

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.

Conditions

Pressure Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Silk-Like Linens

Patients in the experimental arm will be cared for on silk-like bed linens.

Group Type: EXPERIMENTAL

Silk-Like Linens

Intervention Type: OTHER

Synthetic moisture-wicking fabric

Standard Cotton Linens

Patients in the standard of care arm will be cared for on standard cotton bed linens.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Silk-Like Linens

Synthetic moisture-wicking fabric

Intervention Type: OTHER

Other Intervention Names

Dermatherapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Standard Textile

UNKNOWN

Sponsor Role: collaborator

Precision Fabrics Group, Inc.

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mary Montague

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Montague, MSN

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

13-752

Identifier Type: -

Identifier Source: org_study_id