Pressure Incidence Prevention
Conditions
Brief summary
A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury Prevention in the Intensive Care Unit
Detailed description
This was a multi-centre, open, non-comparative, prospective, clinical investigation involving 50 enrolled subjects using competitive enrolment at two sites in the United States of America (USA). The study was conducted on subjects at risk of developing PIs according to investigators' judgment and facility protocol being treated in ICUs. The target subjects were male and female, 18 years and above, with an expected hospital stay of 4-6 days. An evaluable subject was defined as a subject that was enrolled and had data for at least one visit after the baseline visit. There were two parts to the study: Part A: Mepilex Border/Protect Sacrum; Part B: Mepilex Border/Protect Heel (on both left and right heels), used within intended use and according to IFU.
Interventions
DEVICEMepilex Border
Multi-layer Foam Dressings
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is at risk for developing a pressure injury to the heels and/or sacrum * Aged ≥ 18 years * Patient or his/her legal representative is able to understand and voluntarily sign the informed consent * Estimated treatment period in ICU for patient at least 4-6 days
Exclusion criteria
* Patient has a pressure injury or blistering on sacrum and/or heels * Patient with known or suspected sensitivity to any of the components of the products being evaluated * Patient included in other clinical investigations at present or within the last 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 4-6 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wear Time (Days) for First Dressing | 4-6 days | Maximum length of wear time/stay on ability of dressings in ICU. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Mepilex Border Dressing Heel and Sacrum Together 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 | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Transfer from ICU | 32 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Mepilex Border Dressing Heel and Sacrum Together |
|---|---|
| Age, Continuous | 66.9 years STANDARD_DEVIATION 15.7 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 50 |
| other Total, other adverse events | 1 / 50 |
| serious Total, serious adverse events | 7 / 50 |
Outcome results
Primary
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
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).
Time frame: 4-6 days
Population: 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).
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Sacrum | 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 | 1 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 66 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 |
| Mepilex Border Dressing Sacrum | 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 | 1 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 27 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 1 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 49 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 16 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 |
| Mepilex Border Dressing Sacrum | 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 | 25 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 0 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 38 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 16 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 33 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 29 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 0 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 47 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 67 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 1 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 61 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 1 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 2 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 18 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 |
| Mepilex Border Dressing Sacrum | 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 | 24 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 0 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 29 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 |
| Mepilex Border Dressing Sacrum | 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 | 0 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 22 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 4 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 |
| Mepilex Border Dressing Sacrum | 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 | 14 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 20 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 29 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 |
| Mepilex Border Dressing Sacrum | 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 | 44 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 31 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 1 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 |
| Mepilex Border Dressing Sacrum | 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 | 2 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 1 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 26 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 28 Dressing changes evaluated |
| Mepilex Border Dressing Sacrum | 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 | 32 Dressing changes evaluated |
Primary
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
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).
Time frame: 4-6 days
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Heel | 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 |
| Mepilex Border Dressing Sacrum | 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 | 1 Number of dressing changes |
| Mepilex Border Dressing Sacrum | 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 |
| Mepilex Border Dressing Sacrum | 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 | 22 Number of dressing changes |
| Mepilex Border Dressing Sacrum | 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 | 29 Number of dressing changes |
Secondary
Wear Time (Days) for First Dressing
Maximum length of wear time/stay on ability of dressings in ICU.
Time frame: 4-6 days
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepilex Border Dressing Heel | Wear Time (Days) for First Dressing | 0 Day | 2 Participants |
| Mepilex Border Dressing Heel | Wear Time (Days) for First Dressing | 1 Day | 23 Participants |
| Mepilex Border Dressing Heel | Wear Time (Days) for First Dressing | 2 Days | 17 Participants |
| Mepilex Border Dressing Heel | Wear Time (Days) for First Dressing | 3 Days | 4 Participants |
| Mepilex Border Dressing Heel | Wear Time (Days) for First Dressing | 4 Days | 2 Participants |
| Mepilex Border Dressing Heel | Wear Time (Days) for First Dressing | 5 Days | 2 Participants |
| Mepilex Border Dressing Sacrum | Wear Time (Days) for First Dressing | 4 Days | 2 Participants |
| Mepilex Border Dressing Sacrum | Wear Time (Days) for First Dressing | 0 Day | 2 Participants |
| Mepilex Border Dressing Sacrum | Wear Time (Days) for First Dressing | 3 Days | 4 Participants |
| Mepilex Border Dressing Sacrum | Wear Time (Days) for First Dressing | 1 Day | 23 Participants |
| Mepilex Border Dressing Sacrum | Wear Time (Days) for First Dressing | 5 Days | 0 Participants |
| Mepilex Border Dressing Sacrum | Wear Time (Days) for First Dressing | 2 Days | 19 Participants |