Pressure UlcersNCT01403272
Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
A study testing DermaTherapy® Linen and underpads. in people with Pressure Ulcers, run by Precision Fabrics Group, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- DermaTherapy® Linen and underpads.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center
Durham, North Carolina, 27705
About this study
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.
Read the 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.
- Conditions
- Pressure Ulcers
- Being tested
- DermaTherapy® Linen and underpads.
- Keywords
- 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
- Medical subject headings
- Pressure Ulcer, Wounds and Injuries, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermaTherapy® Linen and underpads.Device
Also called DermaTherapy®
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.
| Study group | Role | What they receive |
|---|---|---|
| DermaTherapy® Linen group | Experimental | The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric. Receives: Device: DermaTherapy® Linen and underpads. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly assessments for 1 year
Secondary outcomes (1)
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.
Measured: Weekly for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precision Fabrics Group, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Investigators
- Jack I Twersky, MD, Principal investigator, Durham VA Medical Center, Duke University Medical CenterKenneth E Schmader, MD, Principal investigator, Durham VA medical Center, Duke University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403272
- Sponsor's protocol ID
- VA/DUKE 01457
- Status last verified
- Jul 2011
- First submitted
- 11 May 2011
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
- ClinicalTrials.gov ID
- NCT01403272
- Acronym / sponsor ID
- VA/DUKE 01457
- Conditions
- Pressure Ulcers
- Keywords
- pressure ulcers, stage 1, stage 2, stage 3, stage 4, wounds, sores, infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Precision Fabrics Group, Inc.University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DermaTherapy® Linen group | Experimental | Device: DermaTherapy® Linen and underpads.The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DermaTherapy® Linen and underpads.Also: DermaTherapy®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. | Device | DermaTherapy® Linen group |
Primary outcome
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.
1 secondary outcome
Reduction of bacterial contamination
Time frame: Weekly for 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack I Twersky, MD principal investigator
Durham VA Medical Center, Duke University Medical Center
Kenneth E Schmader, MD principal investigator
Durham VA medical Center, Duke University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DermaTherapy® Linen and underpads. in people with Pressure Ulcers, run by Precision Fabrics Group, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention and reduction in the incidence of pressure ulcers (time frame: Weekly assessments for 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2011.