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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02295735

Enrollment

475

Registered

2014-11-20

Start date

2015-06-30

Completion date

2018-07-31

Last updated

2020-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcer

Keywords

Skin, safety, wounds, intensive care

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.

Interventions

DEVICEMepilex® Border Sacrum and Mepilex® Border Heel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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)
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
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
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
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)
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 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
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)
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

Countries

Germany

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
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.	212
Control Group Standard pressure ulcer prevention according to hospital standard	210
Total	422

Baseline characteristics

Characteristic	Intervention Group	Total	Control Group
Age, Continuous	63.8 years STANDARD_DEVIATION 15.6	63.5 years STANDARD_DEVIATION 15.4	63.1 years STANDARD_DEVIATION 15.2
Body Mass Index	26.4 kg/m² STANDARD_DEVIATION 4.9	26.5 kg/m² STANDARD_DEVIATION 4.9	26.6 kg/m² STANDARD_DEVIATION 4.8
Braden scale score	8.9 units on a scale STANDARD_DEVIATION 1.4	8.9 units on a scale STANDARD_DEVIATION 1.5	9.0 units on a scale STANDARD_DEVIATION 1.6
High Pressure ulcer risk	20 Participants	39 Participants	19 Participants
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment Germany	212 participants	422 participants	210 participants
Sex: Female, Male Female	64 Participants	146 Participants	82 Participants
Sex: Female, Male Male	148 Participants	276 Participants	128 Participants
Very high Pressure ulcer risk	192 Participants	383 Participants	191 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 212	0 / 210
other Total, other adverse events	2 / 212	0 / 210
serious Total, serious adverse events	0 / 212	0 / 210

Outcome results

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)