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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Precision Fabrics Group, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Precision Fabrics Group, Inc.
ClinicalTrials.gov Identifier:
NCT01355666
First received: May 13, 2011
Last updated: May 17, 2011
Last verified: May 2011

May 13, 2011
May 17, 2011
September 2010
May 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01355666 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Pressure Ulcers
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®
Experimental: DermaTherapy® Linen group
The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric.
Intervention: Device: DermaTherapy® Linen and underpads.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
June 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact: Jack I Twersky, MD 919-286-0411 ext 7750 jack.twersky@ya.gov
Contact: Kenneth E Schmader, MD 919-286-0411 ext 6769 kenneth.schmader@va.gov
United States
 
NCT01355666
DermaTherapy
No
Dr. Terry Montgomery, Precision Fabrics Group, inc.
Precision Fabrics Group, Inc.
Department of Veterans Affairs
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
Precision Fabrics Group, Inc.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP