Silicone Adhesive Multilayer Foam Dressings to Prevent Pressure Ulcer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Study Arm 1 (on top of standard of care) Allevyn® brand silicone adhesive multilayer foam dressings 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). |
Device: Allevyn® 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).
|
| Experimental: Study Arm 2 (on top of standard of care) Mepilex® brand silicone adhesive multilayer foam dressings 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). |
Device: Mepilex® 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).
|
| No Intervention: 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). |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
At risk for pressure ulcer development based on Braden risk assessment (Braden score ≤17).
-
Admitted to hospital within the previous 48 hours. Note: Not more than 25% of patients per site should be recruited at ICU wards.
-
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
- 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.
- Written informed consent by the patient or his/her legal representative.
Exclusion Criteria:
-
Aged < 18 years.
-
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.
-
Both heels amputated
-
Previously known/documented allergy for substances used in the devices under study.
-
A clinical condition not allowing participation in a clinical study.
-
Participation in another interventional clinical trial.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OLV Aalst | Aalst | Belgium | 9300 | |
| 2 | AZ Maria Middelares Ghent | Ghent | Belgium | 9000 | |
| 3 | University of Ghent | Ghent | Belgium | 9000 | |
| 4 | UZ Brussel | Jette | Belgium | 1090 | |
| 5 | AZ Groeninge | Kortrijk | Belgium | 8500 | |
| 6 | UZ Leuven | Leuven | Belgium | 3000 | |
| 7 | OLV van Lourdes Ziekenhuis Waregem | Waregem | Belgium | 8790 | |
| 8 | AZ Sint-Elisabeth Zottegem | Zottegem | Belgium | 9620 |
Sponsors and Collaborators
- Belgium Health Care Knowledge Centre
Investigators
- Principal Investigator: Dimitri Beeckman, Ugent
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- KCE-16012
Study Results
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 Detail | 47 participants were excluded; 1 asked to have their data excluded from the analysis and 46 were not randomised. |
| Arm/Group Title | Intervention Group 1 (on Top of Standard of Care) | Intervention Group 2 (on Top of Standard of Care) | Control Group (Standard of Care) |
|---|---|---|---|
| Arm/Group Description | Allevyn® brand silicone adhesive multilayer foam dressings 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). | Mepilex® brand silicone adhesive multilayer foam dressings 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). | 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). |
| Period Title: Overall Study | |||
| STARTED | 542 | 545 | 546 |
| COMPLETED | 534 | 532 | 539 |
| NOT COMPLETED | 8 | 13 | 7 |
Baseline Characteristics
| Arm/Group Title | Intervention Group 1 (on Top of Standard of Care) | Intervention Group 2 (on Top of Standard of Care) | Control Group (Standard of Care) | Total |
|---|---|---|---|---|
| Arm/Group Description | 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). | 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). | 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). | Total of all reporting groups |
| Overall Participants | 542 | 545 | 546 | 1633 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
79.8
(12.3)
|
79.4
(12.5)
|
79.6
(11.7)
|
79.6
(12.2)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
320
59%
|
302
55.4%
|
319
58.4%
|
941
57.6%
|
| Male |
222
41%
|
243
44.6%
|
227
41.6%
|
692
42.4%
|
| Race and Ethnicity Not Collected (Count of Participants) | ||||
| Count of Participants [Participants] |
0
0%
|
|||
| Ward type at study start (Count of Participants) | ||||
| ICU |
65
12%
|
67
12.3%
|
71
13%
|
203
12.4%
|
| Non-ICU |
477
88%
|
478
87.7%
|
475
87%
|
1430
87.6%
|
| Total Braden score (at Baseline) (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
13.0
(2.3)
|
13.1
(2.5)
|
13.0
(2.3)
|
13.0
(2.4)
|
| BMI (kg/m²) (Count of Participants) | ||||
| Underweight (<18.5) |
44
8.1%
|
53
9.7%
|
39
7.1%
|
136
8.3%
|
| Normal weight (18.5-25.0) |
234
43.2%
|
249
45.7%
|
258
47.3%
|
741
45.4%
|
| Overweight (25.0-30.0) |
161
29.7%
|
163
29.9%
|
162
29.7%
|
486
29.8%
|
| Obese (>30.0) |
103
19%
|
80
14.7%
|
87
15.9%
|
270
16.5%
|
| Diabetes (Count of Participants) | ||||
| No diabetes |
419
77.3%
|
427
78.3%
|
412
75.5%
|
1258
77%
|
| Diabetes |
123
22.7%
|
118
21.7%
|
134
24.5%
|
375
23%
|
| Surgery since admission (Count of Participants) | ||||
| No surgery |
484
89.3%
|
486
89.2%
|
489
89.6%
|
1459
89.3%
|
| Surgery |
58
10.7%
|
59
10.8%
|
57
10.4%
|
174
10.7%
|
Outcome Measures
| Title | Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat population (n=1605) |
| Arm/Group Title | Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) | Control Group |
|---|---|---|
| Arm/Group Description | Participants in intervention groups 1 and 2 were cared for on the available support surfaces of the hospital (mattresses, cushions) for the duration of their hospital stay. received standard pressure ulcer prevention strategies (as described in the hospital protocol) which included ongoing risk assessment, regular repositioning and skin care. Silicone adhesive multilayer foam dressings were applied on dry intact skin on sacrum, heel right/left, greater trochanter right/left, in addition to standard pressure ulcer prevention. The maximum treatment duration was 14 days | Participants in control group were cared for on the available support surfaces of the hospital (mattresses, cushions) for the duration of their hospital stay. received standard pressure ulcer prevention strategies (as described in the hospital protocol) which included ongoing risk assessment, regular repositioning and skin care. No silicone adhesive multilayer foam dressings were applied The maximum study duration was 14 days |
| Measure Participants | 1066 | 539 |
| Count of Participants [Participants] |
43
7.9%
|
34
6.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2), Control Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.04 |
| Comments | controlled for type of ward (ICU/Non-ICU) | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 0.64 | |
| Confidence Interval |
(2-Sided) 95% 0.41 to 0.99 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) | Control Group |
|---|---|---|
| Arm/Group Description | Participants in intervention groups 1 and 2 were cared for on the available support surfaces of the hospital (mattresses, cushions) for the duration of their hospital stay. received standard pressure ulcer prevention strategies (as described in the hospital protocol) which included ongoing risk assessment, regular repositioning and skin care. Silicone adhesive multilayer foam dressings were applied on dry intact skin on sacrum, heel right/left, greater trochanter right/left, in addition to standard pressure ulcer prevention. The maximum treatment duration was 14 days | Participants in control group were cared for on the available support surfaces of the hospital (mattresses, cushions) for the duration of their hospital stay. received standard pressure ulcer prevention strategies (as described in the hospital protocol) which included ongoing risk assessment, regular repositioning and skin care. No silicone adhesive multilayer foam dressings were applied The maximum study duration was 14 days |
| Measure Participants | 1066 | 539 |
| Count of Participants [Participants] |
30
5.5%
|
26
4.8%
|
| Title | Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) | Control Group |
|---|---|---|
| Arm/Group Description | Participants in intervention groups 1 and 2 were cared for on the available support surfaces of the hospital (mattresses, cushions) for the duration of their hospital stay. received standard pressure ulcer prevention strategies (as described in the hospital protocol) which included ongoing risk assessment, regular repositioning and skin care. Silicone adhesive multilayer foam dressings were applied on dry intact skin on sacrum, heel right/left, greater trochanter right/left, in addition to standard pressure ulcer prevention. The maximum treatment duration was 14 days | Participants in control group were cared for on the available support surfaces of the hospital (mattresses, cushions) for the duration of their hospital stay. received standard pressure ulcer prevention strategies (as described in the hospital protocol) which included ongoing risk assessment, regular repositioning and skin care. No silicone adhesive multilayer foam dressings were applied The maximum study duration was 14 days |
| Measure Participants | 1066 | 539 |
| Count of Participants [Participants] |
15
2.8%
|
10
1.8%
|
| Title | The Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Trochanter |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) | Control Group |
|---|---|---|
| Arm/Group Description | Participants in intervention groups 1 and 2 were cared for on the available support surfaces of the hospital (mattresses, cushions) for the duration of their hospital stay. received standard pressure ulcer prevention strategies (as described in the hospital protocol) which included ongoing risk assessment, regular repositioning and skin care. Silicone adhesive multilayer foam dressings were applied on dry intact skin on sacrum, heel right/left, greater trochanter right/left, in addition to standard pressure ulcer prevention. The maximum treatment duration was 14 days | Participants in control group were cared for on the available support surfaces of the hospital (mattresses, cushions) for the duration of their hospital stay. received standard pressure ulcer prevention strategies (as described in the hospital protocol) which included ongoing risk assessment, regular repositioning and skin care. No silicone adhesive multilayer foam dressings were applied The maximum study duration was 14 days |
| Measure Participants | 1066 | 539 |
| Count of Participants [Participants] |
1
0.2%
|
0
0%
|
Adverse Events
| Time Frame | They will be recorded between the first usage of the study dressings and the last study related intervention for that patient for Adverse Device Events (ADEs) (usually maximum 14 days) and till 30 days after last study related intervention for SADEs/MDIs. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Only ADEs, SADEs (i.e. AE/SAEs considered related to intervention, the study dressings and their application) and device deficiencies were recorded. The safety population (n=1077) was calculated after exclusion of participants in the ITT population who wanted their data excluded (n=1), who were not randomized (n=46), did not receive at least one dressing (n=10) or received only standard of care (n=546). Skin under the dressings was inspected every day. | |||
| Arm/Group Title | Intervention Group 1 (on Top of Standard of Care) | Intervention Group 2 (on Top of Standard of Care) | ||
| Arm/Group Description | Allevyn® brand silicone adhesive multilayer foam dressings 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). | Mepilex® brand silicone adhesive multilayer foam dressings 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). | ||
All Cause Mortality |
||||
| Intervention Group 1 (on Top of Standard of Care) | Intervention Group 2 (on Top of Standard of Care) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 27/539 (5%) | 23/538 (4.3%) | ||
Serious Adverse Events |
||||
| Intervention Group 1 (on Top of Standard of Care) | Intervention Group 2 (on Top of Standard of Care) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/539 (0%) | 0/538 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Intervention Group 1 (on Top of Standard of Care) | Intervention Group 2 (on Top of Standard of Care) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/539 (3%) | 12/538 (2.2%) | ||
| General disorders | ||||
| Pain at sacrum | 1/539 (0.2%) | 1 | 0/538 (0%) | 0 |
| Infections and infestations | ||||
| Exacerbates athlete's foot | 0/539 (0%) | 0 | 1/538 (0.2%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Patient fall | 2/539 (0.4%) | 2 | 0/538 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Pressure ulcer development | 1/539 (0.2%) | 1 | 2/538 (0.4%) | 2 |
| Erythema | 4/539 (0.7%) | 4 | 4/538 (0.7%) | 4 |
| Pruritus | 3/539 (0.6%) | 3 | 1/538 (0.2%) | 1 |
| Blister formation | 2/539 (0.4%) | 2 | 1/538 (0.2%) | 1 |
| Mechanical skin injuries | 8/539 (1.5%) | 8 | 3/538 (0.6%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Jillian Harrison |
|---|---|
| Organization | Belgian Healthcare Knowledge Centre |
| Phone | +32 2 287 33 89 |
| jillian.harrison@kce.fgov.be |
- KCE-16012