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

NCT02925741 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3343

Last updated 2020-08-13

Study results available
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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

Conditions

  • Pressure Ulcer

Interventions

OTHER

Silk-Like Linens

Synthetic moisture-wicking fabric

Sponsors & Collaborators

  • Standard Textile

    collaborator UNKNOWN

  • Precision Fabrics Group, Inc.

    collaborator OTHER

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Mary Montague, MSN · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02925741 on ClinicalTrials.gov