Pressure Ulcer
Conditions
Brief summary
The objective of this study is to determine if silicone adhesive multilayer foam dressings applied to the sacrum, heels and greater trochanter in addition to standard prevention reduce pressure ulcer incidence category II, III, IV, Unstageable and Deep Tissue Injury (DTI) compared to standard pressure ulcer prevention alone, in at risk hospitalised patients. In particular, this trial extends previous trial results obtained in ICU setting. Therefore, only a maximum of 25% of patients will be recruited from ICU settings. The hypothesis is: 'The use of silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy for pressure ulcer prevention is more effective in reducing pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) incidence rate on sacrum, heels and greater trochanter, compared to standard pressure ulcer prevention alone.' The null hypothesis is: 'The use of silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy for pressure ulcer prevention is not more effective in reducing pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) incidence rate on sacrum, heels and greater trochanter, compared to standard pressure ulcer prevention alone.
Detailed description
A multicentre randomised controlled open label parallel group medical device trial in approximately 8 hospitals in Belgium. Patients will be randomly allocated to three study arms based on a 1:1:1 allocation: Study arm 1 (on top of standard of care): * Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care. * Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith & Nephew (Allevyn® brand). Study arm 2 (on top of standard of care): * Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care. * Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand). Study arm 3 (standard of care): * Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care. * No silicone adhesive multilayer foam dressings will be applied on the skin sites of interest for this trial (sacrum, heel right/left, greater trochanter right/left). Skin sites (restricted to sacrum, heel right/left, greater trochanter right/left) of patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will be assessed daily for a maximum period of 14 days.
Interventions
DEVICEAllevyn® brand silicone adhesive multilayer foam dressings
Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith&Nephew (Allevyn® brand).
DEVICEMepilex® brand silicone adhesive multilayer foam dressings
Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand).
Sponsors
Belgium Health Care Knowledge Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
patients will be allocated to 1 of the 3 study arms based on a 1:1:1 allocation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At risk for pressure ulcer development based on Braden risk assessment (Braden score ≤17). 2. Admitted to hospital within the previous 48 hours. Note: Not more than 25% of patients per site should be recruited at ICU wards. 3. Skin at sacrum is assessable and there is no clinically relevant incontinence- associated dermatitis (IAD\*) or another skin condition that would be a contra-indication for the application of the devices under study, and there is no pressure ulcer category II or worse present. \*clinically relevant IAD is defined as any of the 4 categories described in the publication http://users.ugent.be/\ dibeeckm/globiadnl/nlv1.0.pdf 4. For at least 3 of the following 4 skin sites (heel left, heel right, greater trochanter left, greater trochanter right) one of the following two conditions should apply: \- A study dressing can be applied as prevention of a pressure ulcer category II or worse at that skin site (there is no contra-indication) OR \- There is already a pressure ulcer category II or worse at that skin site. 5. Written informed consent by the patient or his/her legal representative.
Exclusion criteria
1. Aged \< 18 years. 2. The length of stay counting from first day of admission in one or (if the patient is transferred to another ward) more participating wards is \< 7 days. 3. Both heels amputated 4. Previously known/documented allergy for substances used in the devices under study. 5. A clinical condition not allowing participation in a clinical study. 6. Participation in another interventional clinical trial. 7. Patients who exceptionally receive or are planned to receive a dressing for the prevention of pressure ulcers at sacrum, heels and trochanters based on best medical judgment and outside of the surgery setting.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter | assessment during 14 days | The number of participants who developed at least one new pressure ulcer of category 2 or worse on sacrum, heels or greater trochanter as judged onsite, during the study period (maximum 14 days). Patients in experimental groups 1 and 2 were pooled as the treatment group and compared to the control group (in the intention to treat population (n=1605) Note: The International NPUAP/EPUAP Pressure Ulcer Classification System (National Pressure Ulcer Advisory Panel (2014)) distinguishes four categories of pressure ulcers: non-blanchable erythema of the intact skin (category I), partial thickness loss of dermis (category II), full thickness tissue loss (category III) and full thickness tissue loss with exposed bone, tendon or muscle (category IV). Also unstageable pressure ulcers and deep tissue injuries can be recognised. https://npiap.com/ |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum | maximum treatment or study period 14 days | The number of participants who developed at least one new pressure ulcer of category 2 or worse on sacrum as judged onsite, during the study period (maximum 14 days). |
| Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel | maximum treatment or study period 14 days | The number of participants who developed at least one new pressure ulcer of category 2 or worse on any heel as judged onsite, during the study period (maximum 14 days). |
| The Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Trochanter | maximum treatment or study period 14 days | The number of patients who developed at least one new pressure ulcer of category 2 or worse on any greater trochanter as judged onsite, during the study period (maximum 14 days). |
Countries
Belgium
Participant flow
Recruitment details
The study was conducted in 68 wards in 8 hospitals (three university/teaching and five general hospitals) in Flanders, Belgium from February 2018 to December 2018. In total, 1680 participants were screened for eligibility and 1633 participants were randomised to one of the study arms. The number of participants randomised per study site varied between 64 and 287 (median 233). In the intention to treat (ITT) population 12.4% of patients were randomised in the ICU and 87.5% in non-ICUs.
Pre-assignment details
47 participants were excluded; 1 asked to have their data excluded from the analysis and 46 were not randomised.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group 1 (on Top of Standard of Care) Allevyn® brand silicone adhesive multilayer foam dressings
* Participants at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.
* Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith & Nephew (Allevyn® brand). | 542 |
| Intervention Group 2 (on Top of Standard of Care) Mepilex® brand silicone adhesive multilayer foam dressings
* Participants at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.
* Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand). | 545 |
| Control Group (Standard of Care) * Participants at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.
* No silicone adhesive multilayer foam dressings will be applied on the skin sites of interest for this trial (sacrum, heel right/left, greater trochanter right/left). | 546 |
| Total | 1,633 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Not included in analysis as assessed only once and no pressure ulcer or category 1 at any site | 8 | 13 | 7 |
Baseline characteristics
| Characteristic | Intervention Group 1 (on Top of Standard of Care) | Intervention Group 2 (on Top of Standard of Care) | Control Group (Standard of Care) | Total |
|---|---|---|---|---|
| Age, Continuous | 79.8 years STANDARD_DEVIATION 12.3 | 79.4 years STANDARD_DEVIATION 12.5 | 79.6 years STANDARD_DEVIATION 11.7 | 79.6 years STANDARD_DEVIATION 12.2 |
| BMI (kg/m²) Normal weight (18.5-25.0) | 234 Participants | 249 Participants | 258 Participants | 741 Participants |
| BMI (kg/m²) Obese (>30.0) | 103 Participants | 80 Participants | 87 Participants | 270 Participants |
| BMI (kg/m²) Overweight (25.0-30.0) | 161 Participants | 163 Participants | 162 Participants | 486 Participants |
| BMI (kg/m²) Underweight (<18.5) | 44 Participants | 53 Participants | 39 Participants | 136 Participants |
| Diabetes Diabetes | 123 Participants | 118 Participants | 134 Participants | 375 Participants |
| Diabetes No diabetes | 419 Participants | 427 Participants | 412 Participants | 1258 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 320 Participants | 302 Participants | 319 Participants | 941 Participants |
| Sex: Female, Male Male | 222 Participants | 243 Participants | 227 Participants | 692 Participants |
| Surgery since admission No surgery | 484 Participants | 486 Participants | 489 Participants | 1459 Participants |
| Surgery since admission Surgery | 58 Participants | 59 Participants | 57 Participants | 174 Participants |
| Total Braden score (at Baseline) | 13.0 units on a scale STANDARD_DEVIATION 2.3 | 13.1 units on a scale STANDARD_DEVIATION 2.5 | 13.0 units on a scale STANDARD_DEVIATION 2.3 | 13.0 units on a scale STANDARD_DEVIATION 2.4 |
| Ward type at study start ICU | 65 Participants | 67 Participants | 71 Participants | 203 Participants |
| Ward type at study start Non-ICU | 477 Participants | 478 Participants | 475 Participants | 1430 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 27 / 539 | 23 / 538 |
| other Total, other adverse events | 16 / 539 | 12 / 538 |
| serious Total, serious adverse events | 0 / 539 | 0 / 538 |
Outcome results
Primary
Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter
The number of participants who developed at least one new pressure ulcer of category 2 or worse on sacrum, heels or greater trochanter as judged onsite, during the study period (maximum 14 days). Patients in experimental groups 1 and 2 were pooled as the treatment group and compared to the control group (in the intention to treat population (n=1605) Note: The International NPUAP/EPUAP Pressure Ulcer Classification System (National Pressure Ulcer Advisory Panel (2014)) distinguishes four categories of pressure ulcers: non-blanchable erythema of the intact skin (category I), partial thickness loss of dermis (category II), full thickness tissue loss (category III) and full thickness tissue loss with exposed bone, tendon or muscle (category IV). Also unstageable pressure ulcers and deep tissue injuries can be recognised. https://npiap.com/
Time frame: assessment during 14 days
Population: Intention to treat population (n=1605)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) | Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter | 43 Participants |
| Control Group | Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter | 34 Participants |
p-value: 0.0495% CI: [0.41, 0.99]Cochran-Mantel-Haenszel
Other Pre-specified
Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel
The number of participants who developed at least one new pressure ulcer of category 2 or worse on any heel as judged onsite, during the study period (maximum 14 days).
Time frame: maximum treatment or study period 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) | Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel | 15 Participants |
| Control Group | Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel | 10 Participants |
Other Pre-specified
Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum
The number of participants who developed at least one new pressure ulcer of category 2 or worse on sacrum as judged onsite, during the study period (maximum 14 days).
Time frame: maximum treatment or study period 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) | Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum | 30 Participants |
| Control Group | Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum | 26 Participants |
Other Pre-specified
The Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Trochanter
The number of patients who developed at least one new pressure ulcer of category 2 or worse on any greater trochanter as judged onsite, during the study period (maximum 14 days).
Time frame: maximum treatment or study period 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) | The Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Trochanter | 1 Participants |
| Control Group | The Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Trochanter | 0 Participants |