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 : August 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcer||Other: Silk-Like Linens||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3343 participants|
|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)|
|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|
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.
- 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)
- 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.
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
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Mary Montague, MSN||The Cleveland Clinic|