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

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

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

Study Overview

• Status: Completed
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: Mepilex® Border Sacrum and Mepilex® Border Heel

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.

• Study Type: Interventional
• Enrollment (Actual): 475
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charite-Universitatsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mepilex® Border; 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
NO_INTERVENTION: Control; Standard pressure ulcer prevention according to hospital standard

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PD Dr. Jan Kottner

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2015
• Primary Completion (ACTUAL): July 1, 2018
• Study Completion (ACTUAL): July 1, 2018

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (ESTIMATE): November 20, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Skin, safety, wounds, intensive care
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: CRC-PU-A-16