Silicone Adhesive Multilayer Foam Dressings to Prevent Pressure Ulcer

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

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: Allevyn® brand silicone adhesive multilayer foam dressings; Device: Mepilex® brand silicone adhesive multilayer foam dressings

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 Type: Interventional
• Enrollment (Actual): 1634
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • OLV Aalst
  • Ghent, Belgium, 9000
    • Az Maria Middelares Ghent
  • Ghent, Belgium, 9000
    • University of Ghent
  • Jette, Belgium, 1090
    • UZ Brussel
  • Kortrijk, Belgium, 8500
    • Az Groeninge
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Waregem, Belgium, 8790
    • OLV van Lourdes ziekenhuis Waregem
  • Zottegem, Belgium, 9620
    • AZ Sint-Elisabeth Zottegem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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/	assessment during 14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	maximum treatment or study period 14 days
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).	maximum treatment or study period 14 days
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).	maximum treatment or study period 14 days

Collaborators and Investigators

• Sponsor: Belgium Health Care Knowledge Centre
• Investigators: Principal Investigator: Dimitri Beeckman, UGent

Publications and helpful links

General Publications

• 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.

Helpful Links

• Clinical Study Report
• Study webpage

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: KCE-16012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Access will be granted to non-commercial researchers who provide a methodologically sound proposal for a relevant research questions. Relevance will be assessed by the Sponsor in collaboration with the Chief investigator.
• IPD Sharing Time Frame: From 12 months after publication for 5 years.
• IPD Sharing Access Criteria: To achieve aims in the approved proposal. Proposals should be directed to trials@KCE.fgov.be. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No