Trial Outcomes & Findings for Pressure Injury Prevention in the ICU With Multi-Layer Foam Dressings (NCT NCT02962882)
NCT ID: NCT02962882
Last Updated: 2018-03-26
Results Overview
User friendliness judged by site staff, with the following variables; Ability to stay in place Facilitation of inspection Ease of reapplication Conformability to the body Overall impression of dressing \*NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits. Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
4-6 days
Results posted on
2018-03-26
Participant Flow
Investigation period: Sept 2016 - Nov 2016. This study was conducted in two sites in the US, on patients being treated in an ICU who were at risk of developing pressure injuries. The target subjects were male or female, aged 18 years or above, with an expected stay of 4-6 days in an ICU.
Participant milestones
| Measure |
Mepilex Border Dressing All
A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).
Mepilex Border: Multi-layer Foam Dressings
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Mepilex Border Dressing All
A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).
Mepilex Border: Multi-layer Foam Dressings
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Transfer from ICU
|
32
|
Baseline Characteristics
Pressure Injury Prevention in the ICU With Multi-Layer Foam Dressings
Baseline characteristics by cohort
| Measure |
Mepilex Border Dressing Heel and Sacrum Together
n=50 Participants
A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).
Mepilex Border: Multi-layer Foam Dressings
|
|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-6 daysPopulation: ITT population As a dressing change was not required at all visits, the total number of dressing changes evaluated vary for each variable and a question was perhaps not relevant at a given visit (some questions were only relevant for dressing applications, some were only relevant for dressing removals or only relevant for dressing inspections).
User friendliness judged by site staff, with the following variables; Ability to stay in place Facilitation of inspection Ease of reapplication Conformability to the body Overall impression of dressing \*NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits. Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections).
Outcome measures
| Measure |
Mepilex Border Dressing Heel
n=119 Dressing changes evaluated
A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).
Mepilex Border: Multi-layer Foam Dressings
|
Mepilex Border Dressing Sacrum
n=128 Dressing changes evaluated
A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).
Mepilex Border: Multi-layer Foam Dressings
|
|---|---|---|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ease/speed of application of dressing · Poor
|
6 Dressing changes evaluated
|
0 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ease/speed of application of dressing · Very Poor
|
1 Dressing changes evaluated
|
1 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ease/speed of application of dressing · Good
|
14 Dressing changes evaluated
|
16 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ease/speed of application of dressing · Very Good
|
26 Dressing changes evaluated
|
28 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ease/speed of application of dressing · Excellent
|
40 Dressing changes evaluated
|
49 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ease/speed of correct positioning · Very Poor
|
0 Dressing changes evaluated
|
0 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ease/speed of correct positioning · Poor
|
8 Dressing changes evaluated
|
0 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ease/speed of correct positioning · Good
|
14 Dressing changes evaluated
|
16 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ease/speed of correct positioning · Very Good
|
26 Dressing changes evaluated
|
29 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ease/speed of correct positioning · Excellent
|
39 Dressing changes evaluated
|
47 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Non-adherence to skin at removal · Very Poor
|
6 Dressing changes evaluated
|
1 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Non-adherence to skin at removal · Poor
|
6 Dressing changes evaluated
|
1 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Non-adherence to skin at removal · Good
|
17 Dressing changes evaluated
|
18 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Non-adherence to skin at removal · Very Good
|
14 Dressing changes evaluated
|
24 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Non-adherence to skin at removal · Excellent
|
21 Dressing changes evaluated
|
29 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ability to stay in place · Very Poor
|
4 Dressing changes evaluated
|
0 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ability to stay in place · Poor
|
9 Dressing changes evaluated
|
4 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ability to stay in place · Good
|
18 Dressing changes evaluated
|
14 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ability to stay in place · Very Good
|
20 Dressing changes evaluated
|
29 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ability to stay in place · Excellent
|
34 Dressing changes evaluated
|
44 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ability to conform to body contours · Very Poor
|
5 Dressing changes evaluated
|
1 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ability to conform to body contours · Poor
|
11 Dressing changes evaluated
|
2 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ability to conform to body contours · Good
|
22 Dressing changes evaluated
|
26 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ability to conform to body contours · Very Good
|
28 Dressing changes evaluated
|
32 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ability to conform to body contours · Excellent
|
53 Dressing changes evaluated
|
66 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Coverage of bony prominence · Very Poor
|
3 Dressing changes evaluated
|
1 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Coverage of bony prominence · Poor
|
8 Dressing changes evaluated
|
1 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Coverage of bony prominence · Good
|
22 Dressing changes evaluated
|
25 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Coverage of bony prominence · Very Good
|
32 Dressing changes evaluated
|
33 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Coverage of bony prominence · Excellent
|
54 Dressing changes evaluated
|
67 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ease of removal of dressing · Very Poor
|
4 Dressing changes evaluated
|
2 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ease of removal of dressing · Poor
|
7 Dressing changes evaluated
|
0 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ease of removal of dressing · Good
|
20 Dressing changes evaluated
|
22 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ease of removal of dressing · Very Good
|
13 Dressing changes evaluated
|
20 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ease of removal of dressing · Excellent
|
23 Dressing changes evaluated
|
31 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Overall experience · Very Poor
|
4 Dressing changes evaluated
|
1 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Overall experience · Poor
|
14 Dressing changes evaluated
|
1 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Overall experience · Good
|
21 Dressing changes evaluated
|
27 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Overall experience · Very Good
|
29 Dressing changes evaluated
|
38 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Overall experience · Excellent
|
50 Dressing changes evaluated
|
61 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ability to conform to the gluteal cleft · Very Poor
|
—
|
1 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ability to conform to the gluteal cleft · Poor
|
—
|
2 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ability to conform to the gluteal cleft · Good
|
—
|
26 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ability to conform to the gluteal cleft · Very Good
|
—
|
35 Dressing changes evaluated
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Ability to conform to the gluteal cleft · Excellent
|
—
|
62 Dressing changes evaluated
|
PRIMARY outcome
Timeframe: 4-6 daysPopulation: ITT population As a dressing change was not required at all visits, the total number of dressing changes will vary for each variable and a question was perhaps not relevant at a given visit (some questions were only relevant for dressing applications, some were only relevant for dressing removals or only relevant for dressing inspections).
User friendliness judged by site staff, with the following variables; How do you prefer this dressing to your current dressing? \*NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits. Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections).
Outcome measures
| Measure |
Mepilex Border Dressing Heel
n=39 Number of dressing changes
A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).
Mepilex Border: Multi-layer Foam Dressings
|
Mepilex Border Dressing Sacrum
n=58 Number of dressing changes
A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).
Mepilex Border: Multi-layer Foam Dressings
|
|---|---|---|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Much better than
|
6 Number of dressing changes
|
6 Number of dressing changes
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Better than
|
16 Number of dressing changes
|
29 Number of dressing changes
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Equal to
|
10 Number of dressing changes
|
22 Number of dressing changes
|
|
User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication
Not as good as
|
7 Number of dressing changes
|
1 Number of dressing changes
|
SECONDARY outcome
Timeframe: 4-6 daysPopulation: ITT population
Maximum length of wear time/stay on ability of dressings in ICU.
Outcome measures
| Measure |
Mepilex Border Dressing Heel
n=50 Participants
A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).
Mepilex Border: Multi-layer Foam Dressings
|
Mepilex Border Dressing Sacrum
n=50 Participants
A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).
Mepilex Border: Multi-layer Foam Dressings
|
|---|---|---|
|
Wear Time (Days) for First Dressing
1 Day
|
23 Participants
|
23 Participants
|
|
Wear Time (Days) for First Dressing
0 Day
|
2 Participants
|
2 Participants
|
|
Wear Time (Days) for First Dressing
2 Days
|
17 Participants
|
19 Participants
|
|
Wear Time (Days) for First Dressing
3 Days
|
4 Participants
|
4 Participants
|
|
Wear Time (Days) for First Dressing
4 Days
|
2 Participants
|
2 Participants
|
|
Wear Time (Days) for First Dressing
5 Days
|
2 Participants
|
0 Participants
|
Adverse Events
Mepilex Border Dressing All
Serious events: 7 serious events
Other events: 1 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Mepilex Border Dressing All
n=50 participants at risk
A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).
Mepilex Border: Multi-layer Foam Dressings
|
|---|---|
|
General disorders
Death
|
8.0%
4/50 • Number of events 4 • Through study completion, an average of 2 months.
|
|
Infections and infestations
Prolongation of existing hospitalization
|
4.0%
2/50 • Number of events 2 • Through study completion, an average of 2 months.
|
|
Gastrointestinal disorders
Bowel perforation
|
2.0%
1/50 • Number of events 1 • Through study completion, an average of 2 months.
|
Other adverse events
| Measure |
Mepilex Border Dressing All
n=50 participants at risk
A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area and heels at pressure points in patients in the ICU, prone to get pressure injuries (PI).
Mepilex Border: Multi-layer Foam Dressings
|
|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
2.0%
1/50 • Number of events 1 • Through study completion, an average of 2 months.
|
|
Infections and infestations
Worsening Sepsis
|
2.0%
1/50 • Number of events 1 • Through study completion, an average of 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Possible pneumonia and sepsis
|
2.0%
1/50 • Number of events 1 • Through study completion, an average of 2 months.
|
Additional Information
Global Clinical Research Director
Molnlycke Health Care
Phone: +46 31 722 30 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place