Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting

Study Overview
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Brief Summary
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The primary purpose of this research study is to evaluate if DermaTherapy® bedding will significantly reduce pressure ulcer incidence by decreasing maceration, friction, and shearing among residents of Nursing Homes.

Detailed Description
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Additional objectives of this research study are: To evaluate healing of pressure ulcers already present or pressure ulcers that develop during the study. To evaluate the effectiveness of DermaTherapy® bedding and alternative diapers to reduce the potential for bacterial contamination associated with patients' bed linens, underpads, gowns and pajamas, and thereby help reduce the incidence of facility-acquired infections. Study nurses will assess the skin of the subjects once or twice a week for the presence of pressure ulcers and measure the size of the pressure ulcers if they are present. Study nurses will also obtain bacterial culture swabs of the bedding weekly for the first eight weeks of the study from five participants in each group.

Official Title
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Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting

Conditions
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Pressure Ulcers

Intervention / Treatment
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* Device: DermaTherapy® Linen and underpads.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Residents admitted for long term care. Residents admitted for Hospice Care with an expected length of stay greater than one week. Residents with an expected length of stay equal to or greater than 90 days.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DermaTherapy® Linen group<br>The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric. | Device: DermaTherapy® Linen and underpads.<br>* DermaTherapy® Linen is a 100% synthetic silk-like fabric technology designed to provide a cleaner, drier and smoother surface between the skin and support systems for a healthy micro-climate. Subjects in the DermaTherapy® Linen Group are compared to subjects receiving usual care - bed linen made of cotton-blend fabrics.<br>* Other names: DermaTherapy®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention and reduction in the incidence of pressure ulcers | The primary purpose of this research study is to evaluate if DermaTherapy® bedding will significantly reduce pressure ulcer incidence by decreasing maceration, friction, and shearing among residents of Nursing Homes. | Weekly assessments for 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of bacterial contamination | To evaluate the effectiveness of DermaTherapy® bedding to reduce the potential for bacterial contamination associated with patients' bed linens and thereby help reduce the incidence of facility-acquired infections. | Weekly for 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sheets, pressure ulcers, stage 1, stage 2, stage 3, stage 4, wounds, sores, infection, bioburden, bacterial contamination, bed linen, underpad, skin assessment, microclimate, shear, friction, moisture, fabrics, long term care, nursing home, decubitus ulcer, bed ridden, anti-microbial