Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention

Study Overview
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Brief Summary
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The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.

Detailed Description
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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.

Official Title
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A Randomized Controlled Parallel-group Trial to Investigate the Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention Compared to no Dressings

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Device: Mepilex® Border Sacrum and Mepilex® Border Heel


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mepilex® Border<br>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 | Device: Mepilex® Border Sacrum and Mepilex® Border Heel<br> <br> |
| No Intervention: Control<br>Standard pressure ulcer prevention according to hospital standard | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin, safety, wounds, intensive care