Trial Outcomes & Findings for Silk-Like Bed Linens for Prevention of Unit-Acquired Ulcers (NCT NCT02925741)
NCT ID: NCT02925741
Last Updated: 2020-08-13
Results Overview
Total count of the number of patients who developed unit acquired pressure ulcers during the study (count)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3343 participants
Primary outcome timeframe
During MICU admission
Results posted on
2020-08-13
Participant Flow
Eleven patients refused the synthetic linens.
Participant milestones
| Measure |
Silk-like Linen
Patients being cared for on silk-like linens
|
Standard Cotton Linen
Patients being cared for on standard cotton linens
|
|---|---|---|
|
Overall Study
STARTED
|
1637
|
1706
|
|
Overall Study
COMPLETED
|
1626
|
1706
|
|
Overall Study
NOT COMPLETED
|
11
|
0
|
Reasons for withdrawal
| Measure |
Silk-like Linen
Patients being cared for on silk-like linens
|
Standard Cotton Linen
Patients being cared for on standard cotton linens
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
0
|
Baseline Characteristics
Data not available for all subjects. Sex missing from 1 patient in the silk group and 1 patient in the cotton group.
Baseline characteristics by cohort
| Measure |
Silk-like Linen
n=1626 Participants
Patients cared for on silk-like linen.
|
Standard Cotton Linen
n=1706 Participants
Patients cared for on standard cotton linen
|
Total
n=3332 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 16.6 • n=1626 Participants
|
60.3 years
STANDARD_DEVIATION 16.0 • n=1706 Participants
|
60.1 years
STANDARD_DEVIATION 16.3 • n=3332 Participants
|
|
Sex: Female, Male
Female
|
769 Participants
n=1625 Participants • Data not available for all subjects. Sex missing from 1 patient in the silk group and 1 patient in the cotton group.
|
796 Participants
n=1705 Participants • Data not available for all subjects. Sex missing from 1 patient in the silk group and 1 patient in the cotton group.
|
1565 Participants
n=3330 Participants • Data not available for all subjects. Sex missing from 1 patient in the silk group and 1 patient in the cotton group.
|
|
Sex: Female, Male
Male
|
856 Participants
n=1625 Participants • Data not available for all subjects. Sex missing from 1 patient in the silk group and 1 patient in the cotton group.
|
909 Participants
n=1705 Participants • Data not available for all subjects. Sex missing from 1 patient in the silk group and 1 patient in the cotton group.
|
1765 Participants
n=3330 Participants • 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)
American Indian or Alaska Native
|
0 Participants
n=1626 Participants
|
0 Participants
n=1706 Participants
|
0 Participants
n=3332 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1626 Participants
|
0 Participants
n=1706 Participants
|
0 Participants
n=3332 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1626 Participants
|
0 Participants
n=1706 Participants
|
0 Participants
n=3332 Participants
|
|
Race (NIH/OMB)
Black or African American
|
538 Participants
n=1626 Participants
|
499 Participants
n=1706 Participants
|
1037 Participants
n=3332 Participants
|
|
Race (NIH/OMB)
White
|
1010 Participants
n=1626 Participants
|
1104 Participants
n=1706 Participants
|
2114 Participants
n=3332 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1626 Participants
|
0 Participants
n=1706 Participants
|
0 Participants
n=3332 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
78 Participants
n=1626 Participants
|
103 Participants
n=1706 Participants
|
181 Participants
n=3332 Participants
|
|
Diagnostic Category
Cardiovascular
|
505 Participants
n=1565 Participants • Data missing
|
510 Participants
n=1611 Participants • Data missing
|
1015 Participants
n=3176 Participants • Data missing
|
|
Diagnostic Category
Gastrointestinal
|
217 Participants
n=1565 Participants • Data missing
|
250 Participants
n=1611 Participants • Data missing
|
467 Participants
n=3176 Participants • Data missing
|
|
Diagnostic Category
Respiratory
|
508 Participants
n=1565 Participants • Data missing
|
491 Participants
n=1611 Participants • Data missing
|
999 Participants
n=3176 Participants • Data missing
|
|
Diagnostic Category
Hematologic
|
145 Participants
n=1565 Participants • Data missing
|
104 Participants
n=1611 Participants • Data missing
|
249 Participants
n=3176 Participants • Data missing
|
|
Diagnostic Category
Other
|
190 Participants
n=1565 Participants • Data missing
|
256 Participants
n=1611 Participants • Data missing
|
446 Participants
n=3176 Participants • Data missing
|
|
Weight; kgs
|
85.5 kgs
STANDARD_DEVIATION 29.7 • n=1431 Participants • Data missing
|
85.4 kgs
STANDARD_DEVIATION 30.6 • n=1480 Participants • Data missing
|
85.4 kgs
STANDARD_DEVIATION 30.1 • n=2911 Participants • Data missing
|
|
Albumin, mg/dL
|
3.1 mg/dL
STANDARD_DEVIATION 0.71 • n=1599 Participants • Data missing
|
3.0 mg/dL
STANDARD_DEVIATION 0.70 • n=1706 Participants • Data missing
|
3.1 mg/dL
STANDARD_DEVIATION 0.70 • n=3305 Participants • Data missing
|
|
Total Protein, mg/dL
|
6.2 mg/dL
STANDARD_DEVIATION 1.05 • n=1599 Participants • Data missing
|
6.2 mg/dL
STANDARD_DEVIATION 1.01 • n=1644 Participants • Data missing
|
6.2 mg/dL
STANDARD_DEVIATION 1.03 • n=3243 Participants • Data missing
|
|
Braden Score
|
15.5 units on a scale
STANDARD_DEVIATION 3.1 • n=1626 Participants
|
15.4 units on a scale
STANDARD_DEVIATION 3.1 • n=1706 Participants
|
15.4 units on a scale
STANDARD_DEVIATION 3.1 • n=3332 Participants
|
|
APACHE
|
67.5 calculated score (high= high acuity)
STANDARD_DEVIATION 28.7 • n=934 Participants • Missing data
|
66.4 calculated score (high= high acuity)
STANDARD_DEVIATION 27.8 • n=1064 Participants • Missing data
|
66.9 calculated score (high= high acuity)
STANDARD_DEVIATION 28.2 • n=1998 Participants • Missing data
|
|
Admission Type
Outside
|
460 Participants
n=1623 Participants • Data missing
|
484 Participants
n=1702 Participants • Data missing
|
944 Participants
n=3325 Participants • Data missing
|
|
Admission Type
Emergency Department
|
720 Participants
n=1623 Participants • Data missing
|
729 Participants
n=1702 Participants • Data missing
|
1449 Participants
n=3325 Participants • Data missing
|
|
Admission Type
Direct Admission
|
43 Participants
n=1623 Participants • Data missing
|
37 Participants
n=1702 Participants • Data missing
|
80 Participants
n=3325 Participants • Data missing
|
|
Admission Type
Inpatient
|
400 Participants
n=1623 Participants • Data missing
|
452 Participants
n=1702 Participants • Data missing
|
852 Participants
n=3325 Participants • Data missing
|
|
Charlson Comorbidity Index
0
|
309 Participants
n=1623 Participants • Data missing
|
282 Participants
n=1704 Participants • Data missing
|
591 Participants
n=3327 Participants • Data missing
|
|
Charlson Comorbidity Index
1-2
|
599 Participants
n=1623 Participants • Data missing
|
690 Participants
n=1704 Participants • Data missing
|
1289 Participants
n=3327 Participants • Data missing
|
|
Charlson Comorbidity Index
3-4
|
451 Participants
n=1623 Participants • Data missing
|
439 Participants
n=1704 Participants • Data missing
|
890 Participants
n=3327 Participants • Data missing
|
|
Charlson Comorbidity Index
5 or more
|
264 Participants
n=1623 Participants • Data missing
|
293 Participants
n=1704 Participants • Data missing
|
557 Participants
n=3327 Participants • Data missing
|
PRIMARY outcome
Timeframe: During MICU admissionPopulation: Total count and percentage of patients who developed a hospital acquired pressure injury (HAPI)
Total count of the number of patients who developed unit acquired pressure ulcers during the study (count)
Outcome measures
| Measure |
Silk-Like Linen
n=1626 Participants
Patients in the experimental arm will be cared for on silk-like bed linens.
|
Standard Cotton Linen
n=1706 Participants
Patients in the control arm will be cared for on standard cotton linen.
|
|---|---|---|
|
Rate of Development of Unit-acquired Pressure Ulcers
|
45 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Days from admission to HAPIPopulation: Number of days from admission to first HAPI for patients who developed a HAPI
The number of days spent in the intensive care unit prior to the development of a pressure ulcer
Outcome measures
| Measure |
Silk-Like Linen
n=1626 Participants
Patients in the experimental arm will be cared for on silk-like bed linens.
|
Standard Cotton Linen
n=1706 Participants
Patients in the control arm will be cared for on standard cotton linen.
|
|---|---|---|
|
The Time to Develop the First Unit-acquired Pressure Ulcer
|
6 days
Interval 3.0 to 11.0
|
6 days
Interval 3.0 to 10.0
|
SECONDARY outcome
Timeframe: During MICU admissionPopulation: For all patients, maximum stage of HAPI during medical intensive care unit (MICU) stay
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.
Outcome measures
| Measure |
Silk-Like Linen
n=1626 Participants
Patients in the experimental arm will be cared for on silk-like bed linens.
|
Standard Cotton Linen
n=1706 Participants
Patients in the control arm will be cared for on standard cotton linen.
|
|---|---|---|
|
Maximum Severity of Unit Acquired Pressure Injury (UAPI)
Stage 1
|
6 Participants
|
9 Participants
|
|
Maximum Severity of Unit Acquired Pressure Injury (UAPI)
Stage 2-4
|
20 Participants
|
22 Participants
|
|
Maximum Severity of Unit Acquired Pressure Injury (UAPI)
Unstageable
|
15 Participants
|
15 Participants
|
|
Maximum Severity of Unit Acquired Pressure Injury (UAPI)
No HAPI
|
1585 Participants
|
1660 Participants
|
Adverse Events
Silk-like Linens
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Standard Cotton Linens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Silk-like Linens
n=1626 participants at risk
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.
|
Standard Cotton Linens
n=1706 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
CAUTI
|
0.12%
2/1626 • Number of events 2 • 1 year
|
0.00%
0/1706 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place