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

Pressure Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01355666
• Other study ID #: DermaTherapy
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2011
• Last updated: May 17, 2011
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: May 2011
• Source: Precision Fabrics Group, Inc.
• Contact: Jack I Twersky, MD
• Phone: 919-286-0411
• Email: jack.twersky[@]ya.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers

Intervention

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.

Locations

Country	Name	City	State
United States	Durham VA Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Precision Fabrics Group, Inc.	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention and reduction in the incidence of pressure ulcers	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.	Weekly assessments for 1 year	No
Secondary	Reduction of bacterial contamination	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.	Weekly for 8 weeks	No