Silicone Adhesive Multilayer Foam Dressings to Prevent Pressure Ulcer

NCT03442777 | Completed Results

• 1 other identifier: KCE-16012
• Study Type: interventional
• Target: 1,634
• Locations: 1 country
• Sites: 8

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.

Conditions

Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum

  maximum treatment or study period 14 days

• Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Heel

  maximum treatment or study period 14 days

• The Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Any Trochanter

  maximum treatment or study period 14 days

Study Arms (3)

Study Arm 1 (on top of standard of care)

EXPERIMENTAL

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

Study Arm 2 (on top of standard of care)

EXPERIMENTAL

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

Study Arm 3 (standard of care)

NO INTERVENTION

* 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).

Interventions

Allevyn® brand silicone adhesive multilayer foam dressings DEVICE

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 1 (on top of standard of care)

Mepilex® brand silicone adhesive multilayer foam dressings DEVICE

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 2 (on top of standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At risk for pressure ulcer development based on Braden risk assessment (Braden score ≤17).
• Admitted to hospital within the previous 48 hours. Note: Not more than 25% of patients per site should be recruited at ICU wards.
• 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
• 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)
• \- There is already a pressure ulcer category II or worse at that skin site.
• Written informed consent by the patient or his/her legal representative.

You may not qualify if:

• Aged \< 18 years.
• 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.
• Both heels amputated
• Previously known/documented allergy for substances used in the devices under study.
• A clinical condition not allowing participation in a clinical study.
• Participation in another interventional clinical trial.
• 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.

Sponsors & Collaborators

• Belgium Health Care Knowledge Centre: lead

Study Sites (8)

OLV Aalst

Aalst, 9300, Belgium

Location

AZ Maria Middelares Ghent

Ghent, 9000, Belgium

Location

University of Ghent

Ghent, 9000, Belgium

Location

UZ Brussel

Jette, 1090, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

OLV van Lourdes Ziekenhuis Waregem

Waregem, 8790, Belgium

Location

AZ Sint-Elisabeth Zottegem

Zottegem, 9620, Belgium

Location

Related Publications (1)

• 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.

  PMID: 33216969 RESULT

Related Links

• Clinical Study Report
• Study webpage

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Performance and detection bias may have occurred because patients, caregivers and study personnel could not be blinded to the study procedures/devices. All study nurses were trained, and for most hospitals wound care teams were involved when a PU occurred, further strengthening the correct identification of skin injuries.

Results Point of Contact

• Title: Jillian Harrison
• Organization: Belgian Healthcare Knowledge Centre

jillian.harrison@kce.fgov.be

+32 2 287 33 89

Study Officials

• Dimitri Beeckman

  Ugent

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: patients will be allocated to 1 of the 3 study arms based on a 1:1:1 allocation

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 22, 2018
• Study Start: February 8, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 26, 2021
• Results First Posted: April 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

BE (8)