Clinical trial NCT03442777: Silicone Adhesive Multilayer Foam Dressings to Prevent Pressure Ulcer
Official title: Silicone Adhesive Multilayer Foam Dressings as Adjuvant Prophylactic Therapy for Pressure Ulcer (PU) Prevention: a Multicentric Randomised Open Label Parallel Group Medical Device Trial in Hospitalised Patients at Risk of PU Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Lead sponsor: Belgium Health Care Knowledge Centre
Sponsor class: OTHER_GOV
First posted: 2018-02-22
Enrollment: 1634
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients will be allocated to 1 of the 3 study arms based on a 1:1:1 allocation
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter
timeFrame: assessment during 14 days
Secondary outcomes:
Other outcomes:
measure: Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum
timeFrame: maximum treatment or study period 14 days
measure: Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel
timeFrame: maximum treatment or study period 14 days
measure: The Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Trochanter
timeFrame: maximum treatment or study period 14 days
Locations:
city: Aalst
country: Belgium
facility: OLV Aalst
city: Ghent
country: Belgium
facility: AZ Maria Middelares Ghent
city: Ghent
country: Belgium
facility: University of Ghent
city: Jette
country: Belgium
facility: UZ Brussel
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven
city: Waregem
country: Belgium
facility: OLV van Lourdes Ziekenhuis Waregem
city: Zottegem
country: Belgium
facility: AZ Sint-Elisabeth Zottegem
Study officials:
affiliation: Ugent
name: Dimitri Beeckman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beeckman D, Fourie A, Raepsaet C, Van Damme N, Manderlier B, De Meyer D, Beele H, Smet S, Demarre L, Vossaert R, de Graaf A, Verhaeghe L, Vandergheynst N, Hendrickx B, Hanssens V, Keymeulen H, Vanderwee K, Van De Woestijne J, Verhaeghe S, Van Hecke A, Savoye I, Harrison J, Vrijens F, Hulstaert F. Silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospital-acquired pressure ulcers: a pragmatic noncommercial multicentre randomized open-label parallel-group medical device trial. Br J Dermatol. 2021 Jul;185(1):52-61. doi: 10.1111/bjd.19689. Epub 2020 Dec 28.