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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pressure Ulcer
- Sponsor
- PD Dr. Jan Kottner
- Enrollment
- 475
- Locations
- 1
- Primary Endpoint
- Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.
Detailed Description
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.
Investigators
PD Dr. Jan Kottner
PD Dr. rer cur
Charite University, Berlin, Germany
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)
Time Frame: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
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)
Secondary Outcomes
- Number of Preventive Sacrum 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 II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum(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)(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
- 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)(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)(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
- Numbers of Support Surface Used for Pressure Ulcer Prevention (Total)(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
- Number of Preventive Heel Dressings Used for Pressure Ulcer Prevention(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)(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(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)(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
- Follow up Period of Included ICU Patients (Days)(Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)