Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
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|ClinicalTrials.gov Identifier: NCT01403272|
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : July 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcers||Device: DermaTherapy® Linen and underpads.||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||June 2011|
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®
- Prevention and reduction in the incidence of pressure ulcers [ Time Frame: 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.
- Reduction of bacterial contamination [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|