Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
Overview
- Phase
- Not Applicable
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Prevention and reduction in the incidence of pressure ulcers
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Reduction of bacterial contamination(Weekly for 8 weeks)