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

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ClinicalTrials.gov Identifier: NCT02925741
Recruitment Status : Completed
First Posted : October 6, 2016
Results First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
Standard Textile
Precision Fabrics Group, Inc.
Information provided by (Responsible Party):
Mary Montague, 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

Condition or disease Intervention/treatment Phase
Pressure Ulcer Other: Silk-Like Linens Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Trial of Silk-Like Linens for Prevention of Unit-Acquired Pressure Ulcers
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Experimental: Silk-Like Linens
Patients in the experimental arm will be cared for on silk-like bed linens.
Other: Silk-Like Linens
Synthetic moisture-wicking fabric
Other Name: Dermatherapy

No Intervention: Standard Cotton Linens
Patients in the standard of care arm will be cared for on standard cotton bed linens.



Primary Outcome Measures :
  1. Rate of Development of Unit-acquired Pressure Ulcers [ Time Frame: During MICU admission ]
    Total count of the number of patients who developed unit acquired pressure ulcers during the study (count)


Secondary Outcome Measures :
  1. The Time to Develop the First Unit-acquired Pressure Ulcer [ Time Frame: Days from admission to HAPI ]
    The number of days spent in the intensive care unit prior to the development of a pressure ulcer

  2. Maximum Severity of Unit Acquired Pressure Injury (UAPI) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925741


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Standard Textile
Precision Fabrics Group, Inc.
Investigators
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Principal Investigator: Mary Montague, MSN The Cleveland Clinic

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Responsible Party: Mary Montague, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02925741     History of Changes
Other Study ID Numbers: 13-752
First Posted: October 6, 2016    Key Record Dates
Results First Posted: September 25, 2019
Last Update Posted: September 25, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan
Keywords provided by Mary Montague, The Cleveland Clinic:
bed linens
Additional relevant MeSH terms:
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Pressure Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases