COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02925741
Recruitment Status : Completed
First Posted : October 6, 2016
Results First Posted : September 25, 2019
Last Update Posted : August 13, 2020
Sponsor:
Collaborators:
Standard Textile
Precision Fabrics Group, Inc.
Information provided by (Responsible Party):
Mary Montague, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE September 30, 2016
First Posted Date  ICMJE October 6, 2016
Results First Submitted Date  ICMJE July 20, 2017
Results First Posted Date  ICMJE September 25, 2019
Last Update Posted Date August 13, 2020
Study Start Date  ICMJE March 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
The rate of development of unit-acquired pressure ulcers [ Time Frame: The rate at which pressure ulcers developed during the one year study period. ]
The total number of pressure ulcers that developed during the study were counted.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
  • The Time to Develop the First Unit-acquired Pressure Ulcer [ Time Frame: The time from admission to the medical intensive care unit for the first pressure ulcer to develop during the one year study period ]
    The number of days spent in the intensive care unit prior to the development of a pressure ulcer
  • The maximum severity of unit-acquired pressure ulcers [ Time Frame: The highest stage pressure ulcer that developed in the intensive care unit during the one year study period. ]
    Use of National Pressure Ulcer Advisory Panel guidelines to assign highest stage pressure ulcer during the one year study period.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Silk-Like Bed Linens for Prevention of Unit-Acquired Ulcers
Official Title  ICMJE Clinical Trial of Silk-Like Linens for Prevention of Unit-Acquired Pressure Ulcers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Pressure Ulcer
Intervention  ICMJE Other: Silk-Like Linens
Synthetic moisture-wicking fabric
Other Name: Dermatherapy
Study Arms  ICMJE
  • Experimental: Silk-Like Linens
    Patients in the experimental arm will be cared for on silk-like bed linens.
    Intervention: Other: Silk-Like Linens
  • No Intervention: Standard Cotton Linens
    Patients in the standard of care arm will be cared for on standard cotton bed linens.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2020)
3343
Original Actual Enrollment  ICMJE
 (submitted: October 4, 2016)
3332
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02925741
Other Study ID Numbers  ICMJE 13-752
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan
Responsible Party Mary Montague, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE
  • Standard Textile
  • Precision Fabrics Group, Inc.
Investigators  ICMJE
Principal Investigator: Mary Montague, MSN The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP