Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting|
- Prevention and reduction in the incidence of pressure ulcers [ Time Frame: Weekly assessments for 1 year ] [ Designated as safety issue: No ]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.
- Reduction of bacterial contamination [ Time Frame: Weekly for 8 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: DermaTherapy® Linen group
The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric.
Device: DermaTherapy® Linen and underpads.
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.
Other Name: DermaTherapy®
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403272
|United States, North Carolina|
|Durham VA Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Jack I Twersky, MD||Durham VA Medical Center, Duke University Medical Center|
|Principal Investigator:||Kenneth E Schmader, MD||Durham VA medical Center, Duke University Medical Center|