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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. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Precision Fabrics Group, Inc..
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Precision Fabrics Group, Inc.
Collaborator:
VA Office of Research and Development
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
| Tracking Information | |||||||
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| First Received Date ICMJE | May 13, 2011 | ||||||
| Last Updated Date | May 17, 2011 | ||||||
| Start Date ICMJE | September 2010 | ||||||
| Estimated Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures ICMJE |
Reduction of bacterial contamination [ Time Frame: 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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting | ||||||
| Official Title ICMJE | Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting | ||||||
| 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:
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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| Study Type ICMJE | Interventional | ||||||
| Study Phase | Not Provided | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Pressure Ulcers | ||||||
| Intervention ICMJE | 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® |
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| Study Arms | Experimental: DermaTherapy® Linen group
The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric.
Intervention: Device: DermaTherapy® Linen and underpads. |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Unknown status | ||||||
| Estimated Enrollment ICMJE | 75 | ||||||
| Estimated Completion Date | June 2011 | ||||||
| Estimated Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Senior | ||||||
| Accepts Healthy Volunteers | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT01355666 | ||||||
| Other Study ID Numbers ICMJE | DermaTherapy | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement | Not Provided | ||||||
| Responsible Party | Dr. Terry Montgomery, Precision Fabrics Group, inc. | ||||||
| Study Sponsor ICMJE | Precision Fabrics Group, Inc. | ||||||
| Collaborators ICMJE | VA Office of Research and Development | ||||||
| Investigators ICMJE |
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| PRS Account | Precision Fabrics Group, Inc. | ||||||
| Verification Date | May 2011 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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