Trial Outcomes & Findings for Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention (NCT NCT02295735)

NCT ID: NCT02295735

Last Updated: 2020-07-02

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 475 participants
• Primary outcome timeframe: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days
• Results posted on: 2020-07-02

Participant Flow

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.

Participant milestones

Measure	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.	Control Group Standard pressure ulcer prevention according to hospital standard
Overall Study STARTED	238	237
Overall Study COMPLETED	212	210
Overall Study NOT COMPLETED	26	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention Group n=212 Participants 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.	Control Group n=210 Participants Standard pressure ulcer prevention according to hospital standard	Total n=422 Participants Total of all reporting groups
Age, Continuous	63.8 years STANDARD_DEVIATION 15.6 • n=212 Participants	63.1 years STANDARD_DEVIATION 15.2 • n=210 Participants	63.5 years STANDARD_DEVIATION 15.4 • n=422 Participants
Sex: Female, Male Female	64 Participants n=212 Participants	82 Participants n=210 Participants	146 Participants n=422 Participants
Sex: Female, Male Male	148 Participants n=212 Participants	128 Participants n=210 Participants	276 Participants n=422 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Germany	212 participants n=212 Participants	210 participants n=210 Participants	422 participants n=422 Participants
Body Mass Index	26.4 kg/m² STANDARD_DEVIATION 4.9 • n=199 Participants • The analyzed Population differs from the Overall due to missing data	26.6 kg/m² STANDARD_DEVIATION 4.8 • n=202 Participants • The analyzed Population differs from the Overall due to missing data	26.5 kg/m² STANDARD_DEVIATION 4.9 • n=401 Participants • The analyzed Population differs from the Overall due to missing data
Braden scale score	8.9 units on a scale STANDARD_DEVIATION 1.4 • n=212 Participants	9.0 units on a scale STANDARD_DEVIATION 1.6 • n=210 Participants	8.9 units on a scale STANDARD_DEVIATION 1.5 • n=422 Participants
High Pressure ulcer risk	20 Participants n=212 Participants	19 Participants n=210 Participants	39 Participants n=422 Participants
Very high Pressure ulcer risk	192 Participants n=212 Participants	191 Participants n=210 Participants	383 Participants n=422 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Intervention Group n=212 Participants 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.	Control Group n=210 Participants Standard pressure ulcer prevention according to hospital standard
Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)	6 Pressure ulcer	22 Pressure ulcer

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Intervention Group n=212 Participants 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.	Control Group n=210 Participants Standard pressure ulcer prevention according to hospital standard
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)	7.8 Proportion developed / 1000 bed days	30.5 Proportion developed / 1000 bed days

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Intervention Group n=212 Participants 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.	Control Group n=210 Participants Standard pressure ulcer prevention according to hospital standard
Number of Pressure Ulcer Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)	6 Pressure ulcer	28 Pressure ulcer

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Intervention Group n=212 Participants 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.	Control Group n=210 Participants Standard pressure ulcer prevention according to hospital standard
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)	8.0 Proportion developed / 1000 bed days	37.6 Proportion developed / 1000 bed days

SECONDARY outcome

Timeframe: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

Number of preventive sacrum dressings used for pressure ulcer prevention

Outcome measures

Measure	Intervention Group n=212 Participants 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.	Control Group n=210 Participants Standard pressure ulcer prevention according to hospital standard
Number of Preventive Sacrum Dressings Used for Pressure Ulcer Prevention	1050 Dressings	0 Dressings

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Intervention Group n=212 Participants 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.	Control Group n=210 Participants Standard pressure ulcer prevention according to hospital standard
Numbers of Support Surface Used for Pressure Ulcer Prevention (Total) powered - alternating Systems	79 number of support surfaces used	85 number of support surfaces used
Numbers of Support Surface Used for Pressure Ulcer Prevention (Total) Total numbers of support surfaces used	212 number of support surfaces used	209 number of support surfaces used
Numbers of Support Surface Used for Pressure Ulcer Prevention (Total) non-powered systems	149 number of support surfaces used	117 number of support surfaces used
Numbers of Support Surface Used for Pressure Ulcer Prevention (Total) powered - low-air-loss Systems	1 number of support surfaces used	5 number of support surfaces used
Numbers of Support Surface Used for Pressure Ulcer Prevention (Total) other	3 number of support surfaces used	2 number of support surfaces used

SECONDARY outcome

Timeframe: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

• Time to Pressure ulcer development in days

Outcome measures

Measure	Intervention Group n=212 Participants 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.	Control Group n=210 Participants Standard pressure ulcer prevention according to hospital standard
Time to Pressure Ulcer Development of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum	10.8 days Standard Deviation 10.1	13.5 days Standard Deviation 13.8

SECONDARY outcome

Timeframe: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

Number of preventive heel dressings used for pressure ulcer prevention

Outcome measures

Measure	Intervention Group n=212 Participants 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.	Control Group n=210 Participants Standard pressure ulcer prevention according to hospital standard
Number of Preventive Heel Dressings Used for Pressure Ulcer Prevention	2260 Dressings	0 Dressings

SECONDARY outcome

Timeframe: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

• Time to Pressure ulcer development in days

Outcome measures

Measure	Intervention Group n=212 Participants 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.	Control Group n=210 Participants Standard pressure ulcer prevention according to hospital standard
Time to Pressure Ulcer Development of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum	10.8 days Standard Deviation 10.1	13.2 days Standard Deviation 12.4

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Intervention Group n=212 Participants 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.	Control Group n=210 Participants Standard pressure ulcer prevention according to hospital standard
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)	60.7 days Standard Error 4.1	89.0 days Standard Error 9.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Intervention Group n=212 Participants 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.	Control Group n=210 Participants Standard pressure ulcer prevention according to hospital standard
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)	60.7 days Standard Error 4.1	54.6 days Standard Error 9.1

SECONDARY outcome

Timeframe: Duration of hospital stay, an average of 12.6 (SD +/-12.7) days

Follow up period of included ICU patients in mean (days)

Outcome measures

Measure	Intervention Group n=212 Participants 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.	Control Group n=210 Participants Standard pressure ulcer prevention according to hospital standard
Follow up Period of Included ICU Patients (Days)	11.0 days Standard Deviation 10.3	14.3 days Standard Deviation 14.6

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention Group n=212 participants at risk 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.	Control Group n=210 participants at risk Standard pressure ulcer prevention according to hospital standard
Skin and subcutaneous tissue disorders Burning pain and warm sensation under the sacral dressing	0.47% 1/212 • Number of events 1 • Adverse events were recorded every day until the Patient was discharged from the Hospital,an average of 12.6 (SD +/-12.7) days Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. Note: This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved. For users or other persons, this definition is restricted to events related to investigational medical devices.	0.00% 0/210 • Adverse events were recorded every day until the Patient was discharged from the Hospital,an average of 12.6 (SD +/-12.7) days Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. Note: This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved. For users or other persons, this definition is restricted to events related to investigational medical devices.
Skin and subcutaneous tissue disorders Peeling of the outer layers of the skin under the sacral dressing	0.47% 1/212 • Number of events 1 • Adverse events were recorded every day until the Patient was discharged from the Hospital,an average of 12.6 (SD +/-12.7) days Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. Note: This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved. For users or other persons, this definition is restricted to events related to investigational medical devices.	0.00% 0/210 • Adverse events were recorded every day until the Patient was discharged from the Hospital,an average of 12.6 (SD +/-12.7) days Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. Note: This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved. For users or other persons, this definition is restricted to events related to investigational medical devices.

Additional Information

PD Dr. Jan Kottner

Charité Universitätsmedizin Berlin, Department of Dermatology and Allergy

Phone: +4930450518218

Email: jan.kottner@charite.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place