Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Precision Fabrics Group, Inc..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Precision Fabrics Group, Inc.
Collaborator:
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pressure Ulcers |
Device: DermaTherapy® Linen and underpads. |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting |
Resource links provided by NLM:
Further study details as provided by Precision Fabrics Group, Inc.:
Primary Outcome Measures:
- Prevention and reduction in the incidence of pressure ulcers [ Time Frame: Weekly assessments for 1 year ] [ Designated as safety issue: No ]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:
- Reduction of bacterial contamination [ Time Frame: Weekly for 8 weeks ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 75 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DermaTherapy® Linen group
The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric.
|
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®
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355666
Contacts
| Contact: Jack I Twersky, MD | 919-286-0411 ext 7750 | jack.twersky@ya.gov |
| Contact: Kenneth E Schmader, MD | 919-286-0411 ext 6769 | kenneth.schmader@va.gov |
Locations
| United States, North Carolina | |
| Durham VA Medical Center | Recruiting |
| Durham, North Carolina, United States, 27705 | |
| Contact: Jack I Twersky, MD 919-286-0411 ext 7750 jack.twersky@va.gov | |
| Contact: Kenneth E Schmader, MD 919-286-0411 ext 6769 kenneth.schmader@va.gov | |
| Principal Investigator: Jack I Twersky, MD | |
Sponsors and Collaborators
Precision Fabrics Group, Inc.
Investigators
| Principal Investigator: | 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 |
More Information
No publications provided
| Responsible Party: | Dr. Terry Montgomery, Precision Fabrics Group, inc. |
| ClinicalTrials.gov Identifier: | NCT01355666 History of Changes |
| Other Study ID Numbers: | DermaTherapy |
| Study First Received: | May 13, 2011 |
| Last Updated: | May 17, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Precision Fabrics Group, Inc.:
|
pressure ulcers stage 1 stage 2 stage 3 stage 4 wounds sores infection bioburden bacterial contamination bed linen sheets |
underpad skin assessment microclimate shear friction moisture fabrics long term care nursing home decubitus ulcer bed ridden anti-microbial |
Additional relevant MeSH terms:
|
Pressure Ulcer Ulcer Skin Ulcer Skin Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013