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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
Sponsor:
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
Recruitment Details  
Pre-assignment Details Eleven patients refused the synthetic linens.
Arm/Group Title Silk-like Linen Standard Cotton Linen
Hide 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
Arm/Group Title Silk-like Linen Standard Cotton Linen Total
Hide 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
Hide 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
1.Primary Outcome
Title Rate of Development of Unit-acquired Pressure Ulcers
Hide Description Total count of the number of patients who developed unit acquired pressure ulcers during the study (count)
Time Frame During MICU admission
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Silk-like Linens Standard Cotton Linens
Hide 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   --/--      --/--    
Hide 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%)    
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Mary Montague
Organization: Cleveland Clinic
Phone: 216-444-1878
EMail: montagm@ccf.org
Layout table for additonal information
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