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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01355666
Study type Interventional
Source Precision Fabrics Group, Inc.
Contact Jack I Twersky, MD
Phone 919-286-0411
Email jack.twersky@ya.gov
Status Recruiting
Phase N/A
Start date September 2010
Completion date June 2011

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