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

NCT02925741 | Completed Results

• 1 other identifier: 13-752
• Study Type: interventional
• Target: 3,343
• Locations: 1 country
• Sites: 1

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

Conditions

Pressure Ulcer

Keywords

bed linens

Outcome Measures

Primary Outcomes (1)

• Rate of Development of Unit-acquired Pressure Ulcers

  Total count of the number of patients who developed unit acquired pressure ulcers during the study (count)

  During MICU admission

Secondary Outcomes (2)

• The Time to Develop the First Unit-acquired Pressure Ulcer

  Days from admission to HAPI

• Maximum Severity of Unit Acquired Pressure Injury (UAPI)

  During MICU admission

Study Arms (2)

Silk-Like Linens

EXPERIMENTAL

Patients in the experimental arm will be cared for on silk-like bed linens.

Other: Silk-Like Linens

Standard Cotton Linens

NO INTERVENTION

Patients in the standard of care arm will be cared for on standard cotton bed linens.

Interventions

Silk-Like Linens OTHER

Synthetic moisture-wicking fabric

Also known as: Dermatherapy

Silk-Like Linens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted into the medical intensive care unit during the one year study period

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Standard Textile: collaborator
• Precision Fabrics Group, Inc.: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Mary Montague
• Organization: Cleveland Clinic

montagm@ccf.org

216-444-1878

Study Officials

• Mary Montague, MSN

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 6, 2016
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 13, 2020
• Results First Posted: September 25, 2019

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)