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| Name | Class |
|---|---|
| Standard Textile | UNKNOWN |
| Precision Fabrics Group, Inc. | OTHER |
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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
Although there has been a large amount of research published on contributing factors to pressure ulcers, there has been little research related to the role that bed linens play in affecting moisture, friction, and shear that may lead to development of unit-acquired pressure ulcers (UAPU) for patients in acute care settings. This study will use a traditional parallel randomized 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). Patients were randomly assigned by personnel who were blinded to the intervention based on bed availability. Nurses will assess all patients on standard bed linens and silk-like linens for development of 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. Upon entry into the study, all patients will be assessed for baseline skin integrity by the admitting nurse. Demographic data (MRN; unit name; type of linen on bed; admitting diagnosis; dates of admission/discharge; age; gender; race; weight; Braden score; date, location, and stages of UAPU development; lab values (albumin, total protein); and categories of the Charlson Comorbidity Index will be recorded on data collection form by research nurse. Bed linens will be changed per unit protocol. A sample size of 3456 patients is estimated. Patient characteristics will be summarized using frequencies and percentages for categorical factors and means, standard deviations, percentiles and median and range for continuous measures. Comparisons of these patient characteristics, including Braden score, Charlson comorbidity index, unit length of stay and hospital length of stay, will be compared between linen types using generalized linear mixed effect models. 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. In these models, linen type and study period will be used as fixed effects and each unit will be included as a random effect. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silk-Like Linens | Experimental | Patients in the experimental arm will be cared for on silk-like bed linens. |
|
| Standard Cotton Linens | No Intervention | Patients in the standard of care arm will be cared for on standard cotton bed linens. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silk-Like Linens | Other | Synthetic moisture-wicking fabric |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Time to Develop the First Unit-acquired Pressure Ulcer | The number of days spent in the intensive care unit prior to the development of a pressure ulcer | Days from admission to HAPI |
| Maximum Severity of Unit Acquired Pressure Injury (UAPI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Montague, MSN | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
No plan
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Eleven patients refused the synthetic linens.
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| ID | Title | Description |
|---|---|---|
| FG000 | Silk-like Linen | Patients being cared for on silk-like linens |
| FG001 | Standard Cotton Linen | Patients being cared for on standard cotton linens |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Silk-like Linen | Patients cared for on silk-like linen. |
| BG001 | Standard Cotton Linen | Patients cared for on standard cotton linen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Total count and percentage of patients who developed a hospital acquired pressure injury (HAPI) | Posted | Count of Participants | Participants | During MICU admission |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Silk-like Linens | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CAUTI | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Montague | Cleveland Clinic | 216-444-1878 | montagm@ccf.org |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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.
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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.
| During MICU admission |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Data not available for all subjects. Sex missing from 1 patient in the silk group and 1 patient in the cotton group. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Diagnostic Category | Data not available for all subjects. | Data missing | Count of Participants | Participants |
|
| Weight; kgs | Data not available for all subjects. | Data missing | Mean | Standard Deviation | kgs |
|
| Albumin, mg/dL | Data not available for all subjects. | Data missing | Mean | Standard Deviation | mg/dL |
|
| Total Protein, mg/dL | Data not available for all subjects. | Data missing | Mean | Standard Deviation | mg/dL |
|
| Braden Score | 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. | Mean | Standard Deviation | units on a scale |
|
| APACHE | 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. | Missing data | Mean | Standard Deviation | calculated score (high= high acuity) |
|
| Admission Type | Patient's location prior to MICU admission. Data not available for all subjects | Data missing | Count of Participants | Participants |
|
| Charlson Comorbidity Index | 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. | Data missing | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | The Time to Develop the First Unit-acquired Pressure Ulcer | The number of days spent in the intensive care unit prior to the development of a pressure ulcer | Number of days from admission to first HAPI for patients who developed a HAPI | Posted | Median | Inter-Quartile Range | days | Days from admission to HAPI |
|
|
|
| Secondary | Maximum Severity of Unit Acquired Pressure Injury (UAPI) | 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. | For all patients, maximum stage of HAPI during medical intensive care unit (MICU) stay | Posted | Count of Participants | Participants | During MICU admission |
|
|
|
| 0 |
| 1,626 |
| 2 |
| 1,626 |
| EG001 | Standard Cotton Linens | 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. | 0 | 1,706 | 0 | 1,706 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Respiratory |
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| Hematologic |
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| Other |
|
| Direct Admission |
|
| Inpatient |
|
| 3-4 |
|
| 5 or more |
|
| Unstageable |
|
| No HAPI |
|