CClinicalTrials.gg
CompletedNCT01403272Updated Jul 27, 2011

Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting

An interventional study of DermaTherapy® Linen and underpads. in Pressure Ulcers, sponsored by Precision Fabrics Group, Inc.. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2011-07-27.

Sponsored by Precision Fabrics Group, Inc. · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pressure Ulcers

Browse trials for

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
  • nursing home
  • decubitus ulcer
  • bed ridden
  • anti-microbial
03

In context

Pressure Ulcer

518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.

This study's planned enrollment of 75 is close to the median of 70 across 395 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

Precision Fabrics Group, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    DermaTherapy® Linen group

    The DermaTherapy® Linen group uses bed sheets and underpads made with DermaTherapy® fabric.

    Device: DermaTherapy® Linen and underpads.

Interventions

  • DeviceDermaTherapy® 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.

    Also known as: DermaTherapy®

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Weekly for 8 weeks

07

Study locations

1 site
  • Durham VA Medical Center
    Durham, North Carolina 27705, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01403272
Lead sponsor
Precision Fabrics Group, Inc.
Collaborators
US Department of Veterans Affairs
First posted
Jul 27, 2011
Start date
Sep 2010
Primary completion
May 2011
Completion
Jun 2011
Last update
Jul 27, 2011

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion