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

• 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: The Cleveland Clinic
• Collaborators: Standard Textile; Precision Fabrics Group, Inc.
• Information provided by (Responsible Party): Mary Montague, The Cleveland Clinic

Tracking Information

• First Submitted Date: September 30, 2016
• First Posted Date: October 6, 2016
• Results First Submitted Date: July 20, 2017
• Results First Posted Date: September 25, 2019
• Last Update Posted Date: August 13, 2020
• Study Start Date: March 2014
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Silk-Like Bed Linens for Prevention of Unit-Acquired Ulcers
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Pressure Ulcer

Intervention

Other: Silk-Like Linens

Synthetic moisture-wicking fabric

Other Name: Dermatherapy

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 31, 2020): 3343
• Original Actual Enrollment (submitted: October 4, 2016): 3332
• Actual Study Completion Date: March 2015
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02925741
• Other Study ID Numbers: 13-752
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: No plan

• Current Responsible Party: Mary Montague, The Cleveland Clinic
• Original Responsible Party: Same as current
• Current Study Sponsor: The Cleveland Clinic
• Original Study Sponsor: Same as current

Collaborators

• Standard Textile
• Precision Fabrics Group, Inc.

Investigators

• Principal Investigator: Mary Montague, MSN; The Cleveland Clinic

• PRS Account: The Cleveland Clinic
• Verification Date: July 2020