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Silicone Adhesive Multilayer Foam Dressings to Prevent Pressure Ulcer

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ClinicalTrials.gov Identifier: NCT03442777
Recruitment Status : Completed
First Posted : February 22, 2018
Results First Posted : April 26, 2021
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Belgium Health Care Knowledge Centre

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
Pressure Ulcer Device: Allevyn® brand silicone adhesive multilayer foam dressings Device: Mepilex® brand silicone adhesive multilayer foam dressings Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1634 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patients will be allocated to 1 of the 3 study arms based on a 1:1:1 allocation
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : February 8, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

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).



Primary Outcome Measures :
  1. Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter [ Time Frame: 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:
  1. Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum [ Time Frame: 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).

  2. Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel [ Time Frame: 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).

  3. The Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Trochanter [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442777


Locations
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Belgium
OLV Aalst
Aalst, Belgium, 9300
AZ Maria Middelares Ghent
Ghent, Belgium, 9000
University of Ghent
Ghent, Belgium, 9000
UZ Brussel
Jette, Belgium, 1090
AZ Groeninge
Kortrijk, Belgium, 8500
UZ Leuven
Leuven, Belgium, 3000
OLV van Lourdes Ziekenhuis Waregem
Waregem, Belgium, 8790
AZ Sint-Elisabeth Zottegem
Zottegem, Belgium, 9620
Sponsors and Collaborators
Belgium Health Care Knowledge Centre
Investigators
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Principal Investigator: Dimitri Beeckman Ugent
  Study Documents (Full-Text)

Documents provided by Belgium Health Care Knowledge Centre:
Study Protocol  [PDF] January 11, 2018
Statistical Analysis Plan  [PDF] November 5, 2019

Additional Information:
Publications of Results:
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Responsible Party: Belgium Health Care Knowledge Centre
ClinicalTrials.gov Identifier: NCT03442777    
Other Study ID Numbers: KCE-16012
First Posted: February 22, 2018    Key Record Dates
Results First Posted: April 26, 2021
Last Update Posted: April 26, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: From 12 months after publication for 5 years.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pressure Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases