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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DermaTherapy® Linen group | Experimental | The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DermaTherapy® Linen and underpads. | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jack I Twersky, MD | Contact | 919-286-0411 | 7750 | jack.twersky@ya.gov |
| Kenneth E Schmader, MD | Contact | 919-286-0411 | 6769 | kenneth.schmader@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center | Recruiting | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D014947 | Wounds and Injuries |
| D007239 | Infections |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D041342 | Absorbent Pads |
| ID | Term |
|---|---|
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
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