Trial Outcomes & Findings for Silicone Adhesive Multilayer Foam Dressings to Prevent Pressure Ulcer (NCT NCT03442777)

Last Updated: 2021-04-26

Results Overview

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/

Recruitment status

COMPLETED

Study phase

Target enrollment

1634 participants

Primary outcome timeframe

assessment during 14 days

Results posted on

2021-04-26

Participant Flow

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.

47 participants were excluded; 1 asked to have their data excluded from the analysis and 46 were not randomised.

Participant milestones

Participant milestones
Measure	Intervention Group 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).	Intervention Group 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).	Control Group (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).
Overall Study STARTED	542	545	546
Overall Study COMPLETED	534	532	539
Overall Study NOT COMPLETED	8	13	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Group 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).	Intervention Group 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).	Control Group (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).
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

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group 1 (on Top of Standard of Care) n=542 Participants 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).	Intervention Group 2 (on Top of Standard of Care) n=545 Participants 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).	Control Group (Standard of Care) n=546 Participants * 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 n=1633 Participants Total of all reporting groups
Age, Continuous	79.8 years STANDARD_DEVIATION 12.3 • n=542 Participants	79.4 years STANDARD_DEVIATION 12.5 • n=545 Participants	79.6 years STANDARD_DEVIATION 11.7 • n=546 Participants	79.6 years STANDARD_DEVIATION 12.2 • n=1633 Participants
Sex: Female, Male Female	320 Participants n=542 Participants	302 Participants n=545 Participants	319 Participants n=546 Participants	941 Participants n=1633 Participants
Sex: Female, Male Male	222 Participants n=542 Participants	243 Participants n=545 Participants	227 Participants n=546 Participants	692 Participants n=1633 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Ward type at study start ICU	65 Participants n=542 Participants	67 Participants n=545 Participants	71 Participants n=546 Participants	203 Participants n=1633 Participants
Ward type at study start Non-ICU	477 Participants n=542 Participants	478 Participants n=545 Participants	475 Participants n=546 Participants	1430 Participants n=1633 Participants
Total Braden score (at Baseline)	13.0 units on a scale STANDARD_DEVIATION 2.3 • n=542 Participants	13.1 units on a scale STANDARD_DEVIATION 2.5 • n=545 Participants	13.0 units on a scale STANDARD_DEVIATION 2.3 • n=546 Participants	13.0 units on a scale STANDARD_DEVIATION 2.4 • n=1633 Participants
BMI (kg/m²) Underweight (<18.5)	44 Participants n=542 Participants	53 Participants n=545 Participants	39 Participants n=546 Participants	136 Participants n=1633 Participants
BMI (kg/m²) Normal weight (18.5-25.0)	234 Participants n=542 Participants	249 Participants n=545 Participants	258 Participants n=546 Participants	741 Participants n=1633 Participants
BMI (kg/m²) Overweight (25.0-30.0)	161 Participants n=542 Participants	163 Participants n=545 Participants	162 Participants n=546 Participants	486 Participants n=1633 Participants
BMI (kg/m²) Obese (>30.0)	103 Participants n=542 Participants	80 Participants n=545 Participants	87 Participants n=546 Participants	270 Participants n=1633 Participants
Diabetes No diabetes	419 Participants n=542 Participants	427 Participants n=545 Participants	412 Participants n=546 Participants	1258 Participants n=1633 Participants
Diabetes Diabetes	123 Participants n=542 Participants	118 Participants n=545 Participants	134 Participants n=546 Participants	375 Participants n=1633 Participants
Surgery since admission No surgery	484 Participants n=542 Participants	486 Participants n=545 Participants	489 Participants n=546 Participants	1459 Participants n=1633 Participants
Surgery since admission Surgery	58 Participants n=542 Participants	59 Participants n=545 Participants	57 Participants n=546 Participants	174 Participants n=1633 Participants

PRIMARY outcome

Timeframe: assessment during 14 days

Population: Intention to treat population (n=1605)

Outcome measures

Outcome measures
Measure	Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) n=1066 Participants 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	Control Group n=539 Participants 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
Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter	43 Participants	34 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) n=1066 Participants 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	Control Group n=539 Participants 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
Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum	30 Participants	26 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) n=1066 Participants 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	Control Group n=539 Participants 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
Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel	15 Participants	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Treatment Group (Defined in Protocol as Pooled Intervention Group 1 and Intervention Group 2) n=1066 Participants 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	Control Group n=539 Participants 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
The Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Trochanter	1 Participants	0 Participants

Adverse Events

Intervention Group 1 (on Top of Standard of Care)

Serious events: 0 serious events

Other events: 16 other events

Deaths: 27 deaths

Intervention Group 2 (on Top of Standard of Care)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 23 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention Group 1 (on Top of Standard of Care) n=539 participants at risk 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).	Intervention Group 2 (on Top of Standard of Care) n=538 participants at risk 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).
Skin and subcutaneous tissue disorders Pressure ulcer development	0.19% 1/539 • Number of events 1 • 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. 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.	0.37% 2/538 • Number of events 2 • 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. 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.
Skin and subcutaneous tissue disorders Erythema	0.74% 4/539 • Number of events 4 • 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. 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.	0.74% 4/538 • Number of events 4 • 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. 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.
Skin and subcutaneous tissue disorders Pruritus	0.56% 3/539 • Number of events 3 • 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. 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.	0.19% 1/538 • Number of events 1 • 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. 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.
Skin and subcutaneous tissue disorders Blister formation	0.37% 2/539 • Number of events 2 • 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. 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.	0.19% 1/538 • Number of events 1 • 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. 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.
Infections and infestations Exacerbates athlete's foot	0.00% 0/539 • 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. 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.	0.19% 1/538 • Number of events 1 • 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. 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.
Skin and subcutaneous tissue disorders Mechanical skin injuries	1.5% 8/539 • Number of events 8 • 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. 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.	0.56% 3/538 • Number of events 3 • 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. 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.
Injury, poisoning and procedural complications Patient fall	0.37% 2/539 • Number of events 2 • 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. 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.	0.00% 0/538 • 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. 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.
General disorders Pain at sacrum	0.19% 1/539 • Number of events 1 • 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. 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.	0.00% 0/538 • 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. 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.

Additional Information

Jillian Harrison

Belgian Healthcare Knowledge Centre

Phone: +32 2 287 33 89

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place