Pressure Ulcers
Conditions
Keywords
pressure ulcers, stage 1, stage 2, stage 3, stage 4, wounds, sores, infection, bioburden, bacterial contamination, bed linen, sheets, underpad, skin assessment, microclimate, shear, friction, moisture, fabrics, long term care, nursing home, decubitus ulcer, bed ridden, anti-microbial
Brief summary
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
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.
Interventions
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.
Sponsors
US Department of Veterans Affairs
Precision Fabrics Group, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention and reduction in the incidence of pressure ulcers | Weekly assessments for 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of bacterial contamination | Weekly for 8 weeks | 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. |
Countries
United States
Contacts
Primary ContactJack I Twersky, MD
Backup ContactKenneth E Schmader, MD
Outcome results
None listed