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The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.
Patients of intensive acute care and residents of institutional long-term care facilities are at high risk for developing pressure ulcers (PUs). PU standard prevention includes repositioning, early mobilization and the use of special support surfaces. The use of prophylactic dressings might reduce friction and shear forces and/or modify the microclimate of the skin and might therefore protect the skin and underlying tissues from pressure/deformation injury. The primary objective of this study is to determine if preventive silicone dressings (Mepilex® border) applied to the heels and to the sacrum in addition to PU standard prevention reduces PU incidence category II, III, IV, and deep tissue injury compared to PU standard alone in at risk hospital patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepilex® Border | Experimental | If a patient is assigned to the intervention group the dressings Mepilex® Border Sacrum and Mepilex® Border Heel will be applied onto the respective intact skin areas in addition to standard pressure ulcer prevention |
|
| Control | No Intervention | Standard pressure ulcer prevention according to hospital standard |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex® Border Sacrum and Mepilex® Border Heel | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion) | The primary outcome was the cumulative incidence of Pressure ulcer category II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcers were categorized according to the NPUAP/EPUAP 2014 classification System. The occurrence of a new pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown) | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
| Measure | Description | Time Frame |
|---|---|---|
| Density Rate of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate) | The Incidence density of Pressure Ulcer category II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown) |
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Major trauma patients and/or critically ill patients (e.g. with cardiac arrest) admitted to the emergency department and being transferred and/or admitted directly to a surgical or internal ICU
Being at "high" or "very high" PU risk according to the Charité PU prevention standard:
- Category 3 (= partly care dependent/limited mobility in bed), 4A (= care depended, limited mobility in bed), 4B (= totally immobile) according to the Jones classification modified by Charité
Expected minimum length of stay at least three days
Informed consent (or by legal representative)
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| Name | Affiliation | Role |
|---|---|---|
| Jan Kottner, PhD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité-Universitätsmedizin Berlin | Berlin | 10117 | Germany |
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The study was conducted in a tertiary care hospital from June 2015 to July 2018 at the Charite Universitaetsmedizin Berlin, Germany. Patients were recruited from seven ICUs.
In total, 7575 ICU patients were screened for eligibility and 475 ICU patients were included.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care. |
| FG001 | Control Group | Standard pressure ulcer prevention according to hospital standard |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care. |
| BG001 |
| 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 | Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion) | The primary outcome was the cumulative incidence of Pressure ulcer category II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcers were categorized according to the NPUAP/EPUAP 2014 classification System. The occurrence of a new pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown) | Posted | Number | Pressure ulcer | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
|
Adverse events were recorded every day until the Patient was discharged from the Hospital,an average of 12.6 (SD +/-12.7) days
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device.
Note: This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved. For users or other persons, this definition is restricted to events related to investigational medical devices.
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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 | Intervention Group | For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning pain and warm sensation under the sacral dressing | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PD Dr. Jan Kottner | Charité Universitätsmedizin Berlin, Department of Dermatology and Allergy | +4930450518218 | jan.kottner@charite.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2015 | May 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
| Number of Pressure Ulcer Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion) | The the cumulative incidence of Pressure ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown) | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
| Number of Pressure Ulcers Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate) | The Incidence density of Pressure Ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown) | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
| Number of Preventive Sacrum Dressings Used for Pressure Ulcer Prevention | Number of preventive sacrum dressings used for pressure ulcer prevention | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
| Numbers of Support Surface Used for Pressure Ulcer Prevention (Total) | Support surface categories were recorded. Please see the different types in the Outcome measure data table | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
| Time to Pressure Ulcer Development of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum | • Time to Pressure ulcer development in days | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
| Number of Preventive Heel Dressings Used for Pressure Ulcer Prevention | Number of preventive heel dressings used for pressure ulcer prevention | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
| Time to Pressure Ulcer Development of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum | • Time to Pressure ulcer development in days | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
| Event Free Survival Time of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis) | • Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
| Event Free Survival Time of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis) | • Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
| Follow up Period of Included ICU Patients (Days) | Follow up period of included ICU patients in mean (days) | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
| Control Group |
Standard pressure ulcer prevention according to hospital standard |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | The analyzed Population differs from the Overall due to missing data | Mean | Standard Deviation | kg/m² |
|
| Braden scale score | The Braden scale is a standardized six item Pressure ulcer risk assessment instrument with scores ranging from 6 (= high Pressure ulcer risk) to 23 (= no Pressure ulcer risk). | Mean | Standard Deviation | units on a scale |
|
| High Pressure ulcer risk | According to Hospital Standard | Count of Participants | Participants |
|
| Very high Pressure ulcer risk | According to Hospital Standard | Count of Participants | Participants |
|
| OG001 | Control Group | Standard pressure ulcer prevention according to hospital standard |
|
|
| Secondary | Density Rate of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate) | The Incidence density of Pressure Ulcer category II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown) | Posted | Number | Proportion developed / 1000 bed days | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
|
|
|
| Secondary | Number of Pressure Ulcer Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion) | The the cumulative incidence of Pressure ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown) | Posted | Number | Pressure ulcer | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
|
|
|
| Secondary | Number of Pressure Ulcers Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate) | The Incidence density of Pressure Ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown) | Posted | Number | Proportion developed / 1000 bed days | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
|
|
|
| Secondary | Number of Preventive Sacrum Dressings Used for Pressure Ulcer Prevention | Number of preventive sacrum dressings used for pressure ulcer prevention | Posted | Number | Dressings | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
|
|
|
| Secondary | Numbers of Support Surface Used for Pressure Ulcer Prevention (Total) | Support surface categories were recorded. Please see the different types in the Outcome measure data table | Posted | Number | number of support surfaces used | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
|
|
|
| Secondary | Time to Pressure Ulcer Development of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum | • Time to Pressure ulcer development in days | Posted | Mean | Standard Deviation | days | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
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|
|
| Secondary | Number of Preventive Heel Dressings Used for Pressure Ulcer Prevention | Number of preventive heel dressings used for pressure ulcer prevention | Posted | Number | Dressings | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
|
|
|
| Secondary | Time to Pressure Ulcer Development of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum | • Time to Pressure ulcer development in days | Posted | Mean | Standard Deviation | days | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
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|
|
| Secondary | Event Free Survival Time of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis) | • Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days | Posted | Mean | Standard Error | days | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
|
|
|
| Secondary | Event Free Survival Time of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis) | • Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days | Posted | Mean | Standard Error | days | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
|
|
|
| Secondary | Follow up Period of Included ICU Patients (Days) | Follow up period of included ICU patients in mean (days) | Posted | Mean | Standard Deviation | days | Duration of hospital stay, an average of 12.6 (SD +/-12.7) days |
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|
| 0 |
| 212 |
| 0 |
| 212 |
| 2 |
| 212 |
| EG001 | Control Group | Standard pressure ulcer prevention according to hospital standard | 0 | 210 | 0 | 210 | 0 | 210 |
| Peeling of the outer layers of the skin under the sacral dressing | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| powered - alternating Systems |
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| powered - low-air-loss Systems |
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| other |
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