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Silicone Adhesive Multilayer Foam Dressings to Prevent Pressure Ulcer

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ClinicalTrials.gov Identifier: NCT03442777
Recruitment Status : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Belgium Health Care Knowledge Centre

Tracking Information
First Submitted Date  ICMJE February 16, 2018
First Posted Date  ICMJE February 22, 2018
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE February 8, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
Incidence of new pressure ulcer [ Time Frame: assessment during 14 days ]
The incidence rate during the study period of the patient of at least one new pressure ulcer category II or more on sacrum, heels and greater trochanter
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03442777 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Silicone Adhesive Multilayer Foam Dressings to Prevent Pressure Ulcer
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Pressure Ulcer
Intervention  ICMJE
  • 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).
  • 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).
Study Arms  ICMJE
  • 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).
    Intervention: Device: Allevyn® brand silicone adhesive multilayer foam dressings
  • 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).
    Intervention: Device: Mepilex® brand silicone adhesive multilayer foam dressings
  • 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 15, 2019)
1634
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2018)
1662
Estimated Study Completion Date  ICMJE March 31, 2019
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03442777
Other Study ID Numbers  ICMJE KCE-16012
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The method of selection and other details to be provided.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: at least 18 months after Data Base Lock
Responsible Party Belgium Health Care Knowledge Centre
Study Sponsor  ICMJE Belgium Health Care Knowledge Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dimitri Beeckman Ugent
PRS Account Belgium Health Care Knowledge Centre
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP