N/A
N=3,343
Silk-Like Bed Linens for Prevention of Unit-Acquired Ulcers
Pressure Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT02925741 ↗Enrolled (actual)
3,343
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Rate of Development of Unit-acquired Pressure Ulcers — 45; 42 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Silk-Like Linens (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Development of Unit-acquired Pressure Ulcers |
45; 42 | — |
| SECONDARY The Time to Develop the First Unit-acquired Pressure Ulcer |
6; 6 | — |
| SECONDARY Maximum Severity of Unit Acquired Pressure Injury (UAPI) |
6; 9; 20; 22; 15; 15 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT02925741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.