Recruiting

Observational Study

Sponsor:

Precision Fabrics Group, Inc.

Code:

NCT01355666

Conditions

Pressure Ulcers

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

DermaTherapy® Linen and underpads.

Study Details

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.

Conditions

Pressure Ulcers

Study ID

NCT01355666

Start date

Sep, 2010

Status verified date

May, 2011

Completion date

Jun, 2011

Anticipated

Primary completion date

May, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: DermaTherapy® Linen group

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

Interventions

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.

Primary outcome measure

  • Prevention and reduction in the incidence of pressure ulcers [ Time Frame: Weekly assessments for 1 year ]

Central Contacts and Locations

Central contacts

Jack I Twersky, MD

919-286-0411jack.twersky@ya.gov

Kenneth E Schmader, MD

919-286-0411kenneth.schmader@va.gov

Locations

Durham VA Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Jack I Twersky, MD

919-286-0411jack.twersky@va.gov

Kenneth E Schmader, MD

919-286-0411kenneth.schmader@va.gov

Principal Investigator:

Jack I Twersky, MD

More Information

Sponsor

Precision Fabrics Group, Inc.

Last update posted

May 18, 2011

Last verified

May, 2011

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Precision Fabrics Group, Inc. on 2011-05-18.