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

Not Applicable

Completed

Conditions: Pressure Ulcer

Interventions: Device: Mepilex® Border Sacrum and Mepilex® Border Heel

Registration Number: NCT02295735

Lead Sponsor: PD Dr. Jan Kottner

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 475

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mepilex® Border	Mepilex® Border Sacrum and Mepilex® Border Heel	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

Primary Outcome Measures

Name	Time	Method
Number of Pressure Ulcers Category 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	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 Outcome Measures

Name	Time	Method
Number of Preventive Sacrum Dressings Used for Pressure Ulcer Prevention	Duration of hospital stay, an average of 12.6 (SD +/-12.7) days	Number of preventive sacrum dressings used for pressure ulcer prevention
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	• Time to Pressure ulcer development in 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	• Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in 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	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)
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	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)
Numbers of Support Surface Used for Pressure Ulcer Prevention (Total)	Duration of hospital stay, an average of 12.6 (SD +/-12.7) days	Support surface categories were recorded. Please see the different types in the Outcome measure data table
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 preventive heel dressings used for pressure ulcer prevention
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	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)
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	• Time to Pressure ulcer development in 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	• Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days
Follow up Period of Included ICU Patients (Days)	Duration of hospital stay, an average of 12.6 (SD +/-12.7) days	Follow up period of included ICU patients in mean (days)