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

Tracking Information
First Submitted Date ICMJE	May 13, 2011
First Posted Date ICMJE	May 18, 2011
Last Update Posted Date	May 18, 2011
Study Start Date ICMJE	September 2010
Estimated Primary Completion Date	May 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 17, 2011)	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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: May 17, 2011)	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.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
Official Title ICMJE	Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Pressure Ulcers
Intervention ICMJE	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®
Study Arms	Experimental: DermaTherapy® Linen group; The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric.; Intervention: Device: DermaTherapy® Linen and underpads.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: May 17, 2011)	75
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	June 2011
Estimated Primary Completion Date	May 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01355666
Other Study ID Numbers ICMJE	DermaTherapy
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Dr. Terry Montgomery, Precision Fabrics Group, inc.
Study Sponsor ICMJE	Precision Fabrics Group, Inc.
Collaborators ICMJE	VA Office of Research and Development
Investigators ICMJE	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
PRS Account	Precision Fabrics Group, Inc.
Verification Date	May 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP