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

Not Applicable

• Conditions: Pressure Ulcers
• Interventions: Device: DermaTherapy® Linen and underpads.

• Registration Number: NCT01355666
• Lead Sponsor: Precision Fabrics Group, Inc.

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 Timeline

• Study Start: 2010-09
• Status Verified: 2011-05
• Primary Completion: 2011-05
• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-17
• Last Update Submitted: 2011-05-17
• Study First Posted: 2011-05-18
• Last Update Posted: 2011-05-18
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DermaTherapy® Linen group	DermaTherapy® Linen and underpads.	The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric.

Primary Outcome Measures

Name	Time	Method
Prevention and reduction in the incidence of pressure ulcers	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.

Secondary Outcome Measures

Name	Time	Method
Reduction of bacterial contamination	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.

Trial Locations

Locations (1)

Durham VA Medical Center; 🇺🇸 Durham, North Carolina, United States