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

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Pressure Ulcer
• Intervention: Other: Silk-Like Linens
• Enrollment: 3343

Participant Flow

Recruitment Details
Pre-assignment Details	Eleven patients refused the synthetic linens.

Arm/Group Title	Silk-like Linen	Standard Cotton Linen
Arm/Group Description	Patients being cared for on silk-like linens	Patients being cared for on standard cotton linens
Period Title: Overall Study
Started	1637	1706
Completed	1626	1706
Not Completed	11	0
Reason Not Completed
Withdrawal by Subject	11	0

Baseline Characteristics

Arm/Group Title		Silk-like Linen	Standard Cotton Linen	Total
Arm/Group Description		Patients cared for on silk-like linen.	Patients cared for on standard cotton linen	Total of all reporting groups
Overall Number of Baseline Participants		1626	1706	3332
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	1626 participants	1706 participants	3332 participants
		60 (16.6)	60.3 (16.0)	60.1 (16.3)
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1625 participants	1705 participants	3330 participants
	Female	769 47.3%	796 46.7%	1565 47.0%
	Male	856 52.7%	909 53.3%	1765 53.0%
		[1] Measure Analysis Population Description: Data not available for all subjects. Sex missing from 1 patient in the silk group and 1 patient in the cotton group.
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1626 participants	1706 participants	3332 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	538 33.1%	499 29.2%	1037 31.1%
	White	1010 62.1%	1104 64.7%	2114 63.4%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	78 4.8%	103 6.0%	181 5.4%
Diagnostic Category [1] [2]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1565 participants	1611 participants	3176 participants
	Cardiovascular	505 32.3%	510 31.7%	1015 32.0%
	Gastrointestinal	217 13.9%	250 15.5%	467 14.7%
	Respiratory	508 32.5%	491 30.5%	999 31.5%
	Hematologic	145 9.3%	104 6.5%	249 7.8%
	Other	190 12.1%	256 15.9%	446 14.0%
		[1] Measure Description: Data not available for all subjects.; [2] Measure Analysis Population Description: Data missing
Weight; kgs [1] [2]; Mean (Standard Deviation); Unit of measure: Kgs
	Number Analyzed	1431 participants	1480 participants	2911 participants
		85.5 (29.7)	85.4 (30.6)	85.4 (30.1)
		[1] Measure Description: Data not available for all subjects.; [2] Measure Analysis Population Description: Data missing
Albumin, mg/dL [1] [2]; Mean (Standard Deviation); Unit of measure: mg/dL
	Number Analyzed	1599 participants	1706 participants	3305 participants
		3.1 (0.71)	3.0 (0.70)	3.1 (0.70)
		[1] Measure Description: Data not available for all subjects.; [2] Measure Analysis Population Description: Data missing
Total Protein, mg/dL [1] [2]; Mean (Standard Deviation); Unit of measure: mg/dL
	Number Analyzed	1599 participants	1644 participants	3243 participants
		6.2 (1.05)	6.2 (1.01)	6.2 (1.03)
		[1] Measure Description: Data not available for all subjects.; [2] Measure Analysis Population Description: Data missing
Braden Score [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	1626 participants	1706 participants	3332 participants
		15.5 (3.1)	15.4 (3.1)	15.4 (3.1)
		[1] Measure Description: Measure Description: The Braden Scale is a valid and reliable tool which determines a patient's risk for developing a pressure ulcer. It consists of six individual subsets: sensory perception, moisture, activity, mobility, nutrition, and friction/shear. All subsets, with the exception of friction/shear are measured on a 1-4 scale; friction/shear measured on a 1-3 scale. The total score can range from 6 indicating a high risk of pressure injury development to 23 indicating low risk of pressure injury development. The level of risk dictates the intervention strategies that should be used.
APACHE [1] [2]; Mean (Standard Deviation); Unit of measure: Calculated score (high= high acuity)
	Number Analyzed	934 participants	1064 participants	1998 participants
		67.5 (28.7)	66.4 (27.8)	66.9 (28.2)
		[1] Measure Description: APACHE II ("Acute Physiology And Chronic Health Evaluation II") is a severity-of-disease classification system, one of several ICU scoring systems. It is applied within 24 hours of admission of a patient to an intensive care unit (ICU): an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death Data not available for all subjects.; [2] Measure Analysis Population Description: Missing data
Admission Type [1] [2]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1623 participants	1702 participants	3325 participants
	Outside	460 28.3%	484 28.4%	944 28.4%
	Emergency Department	720 44.4%	729 42.8%	1449 43.6%
	Direct Admission	43 2.6%	37 2.2%	80 2.4%
	Inpatient	400 24.6%	452 26.6%	852 25.6%
		[1] Measure Description: Patient's location prior to MICU admission. Data not available for all subjects; [2] Measure Analysis Population Description: Data missing
Charlson Comorbidity Index [1] [2]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1623 participants	1704 participants	3327 participants
	0	309 19.0%	282 16.5%	591 17.8%
	1-2	599 36.9%	690 40.5%	1289 38.7%
	3-4	451 27.8%	439 25.8%	890 26.8%
	5 or more	264 16.3%	293 17.2%	557 16.7%
		[1] Measure Description: The categories are based on the sum of the weights. The categories are risk stratification groupings created by the instrument developer. There is a stepwise increase in the observed mortality with a higher comorbidity index, within each of the severity groups.; [2] Measure Analysis Population Description: Data missing

Outcome Measures

1. Primary Outcome

Title	Rate of Development of Unit-acquired Pressure Ulcers
Description	Total count of the number of patients who developed unit acquired pressure ulcers during the study (count)
Time Frame	During MICU admission

Outcome Measure Data

Analysis Population Description

Total count and percentage of patients who developed a hospital acquired pressure injury (HAPI)

Arm/Group Title	Silk-Like Linen	Standard Cotton Linen
Arm/Group Description:	Patients in the experimental arm will be cared for on silk-like bed linens.	Patients in the control arm will be cared for on standard cotton linen.
Overall Number of Participants Analyzed	1626	1706
Measure Type: Count of Participants; Unit of Measure: Participants
	45 2.8%	42 2.5%

2. Secondary Outcome

Title	The Time to Develop the First Unit-acquired Pressure Ulcer
Description	The number of days spent in the intensive care unit prior to the development of a pressure ulcer
Time Frame	Days from admission to HAPI

Outcome Measure Data

Analysis Population Description

Number of days from admission to first HAPI for patients who developed a HAPI

Arm/Group Title	Silk-Like Linen	Standard Cotton Linen
Arm/Group Description:	Patients in the experimental group will be cared for on silk-like linen.	Patients in the control group will be cared for on standard cotton linen.
Overall Number of Participants Analyzed	1626	1706
Median (Inter-Quartile Range); Unit of Measure: days
	6; (3 to 11)	6; (3 to 10)

3. Secondary Outcome

Title	Maximum Severity of Unit Acquired Pressure Injury (UAPI)
Description	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.
Time Frame	During MICU admission

Outcome Measure Data

Analysis Population Description

For all patients, maximum stage of HAPI during medical intensive care unit (MICU) stay

Arm/Group Title	Silk-Like Linen	Standard Cotton Linen
Arm/Group Description:	Patients in the experimental group will be cared for on silk-like linen.	Patients in the control group were cared for on standard cotton linen.
Overall Number of Participants Analyzed	1626	1706
Measure Type: Count of Participants; Unit of Measure: Participants
Stage 1	6 0.4%	9 0.5%
Stage 2-4	20 1.2%	22 1.3%
Unstageable	15 0.9%	15 0.9%
No HAPI	1585 97.5%	1660 97.3%

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Silk-like Linens		Standard Cotton Linens
Arm/Group Description	This study will use a traditional parallel randomization design with patients in five medical intensive care units. Patients were assigned to groups based on bed availability by personnel who were blinded to linens used on those units. Each unit used the linens assigned by the randomization procedure for six months followed by a fourteen day washout period. Patient participation was based on the unit to which they were assigned.		This study will use a traditional parallel randomization design with patients in five medical intensive care units. Patients were assigned to groups based on bed availability by personnel who were blinded to linens used on those units. Each unit used the linens assigned by the randomization procedure for six months followed by a fourteen day washout period. Patient participation was based on the unit to which they were assigned.
All-Cause Mortality
	Silk-like Linens		Standard Cotton Linens
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Silk-like Linens		Standard Cotton Linens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1626 (0.00%)		0/1706 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Silk-like Linens		Standard Cotton Linens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/1626 (0.12%)		0/1706 (0.00%)
Infections and infestations
CAUTI †	2/1626 (0.12%)	2	0/1706 (0.00%)	0
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Mary Montague
• Organization: Cleveland Clinic
• Phone: 216-444-1878
• EMail: montagm@ccf.org

• Responsible Party: Mary Montague, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT02925741
• Other Study ID Numbers: 13-752
• First Submitted: September 30, 2016
• First Posted: October 6, 2016
• Results First Submitted: July 20, 2017
• Results First Posted: September 25, 2019
• Last Update Posted: August 13, 2020