The Analysis of Skin Temperature by Long Wave Infrared Imaging to Determine Its Effectiveness as a Predictor of Tissue Injury

April 21, 2008 updated by: Trillennium Medical Imaging, Inc.

Study of Thermal Imaging as an Objective RISK Indicator; The Evaluation of Skin Blood Flow and Temperature by Long Wave Infra-Red Imaging to Determine Effectiveness as a Predictor of Pressure Ulcer or Non-Visible Deep Tissue Damage

Long-wave infrared imaging can be used to identify skin temperature changes associated with underlying tissue changes. We want to determine if the use of Long Wave infrared Imaging is as effective as the Braden Score in predicting nosocomial pressure ulcers.

Study Overview

Status

Unknown

Conditions

Detailed Description

The Trillennium Medical Imaging system will be used to gather skin temperature data on 100 subjects. The subjects will be enrolled from Duke North floors 8100 or 8300 in a prospective controlled trial. All eligible patients who have signed a consent form will be assessed using the Long Wave Infrared imaging.

Subjects eligible for this study who have signed a consent form will be scanned on bilateral heels and sacrum. Subjects with ulcers on those areas will also be scanned due to the fact that they are at a high risk of developing additional pressure ulcers. The intent is not to capture images of the existing ulcer, but to focus on areas that could potentially develop into additional pressure ulcers. The subjects who already have an ulcer will only be scanned on non ulcerated tissue. The areas of interest must be off-loaded for 3 minutes from any pressure in order to acclimate to ambient temperature. The device will be held approximately 36 inches from the area of interest in order to obtain an image. The subjects will be assessed within 24 hours of admission and every 24 hours until discharge or they develop a pressure ulcer. The subject's routinely recorded Braden scores (By on the floor nursing staff) will also be captured in order to effectively compare the effectiveness of the Imaging system. The nurse conducting the imaging will also record a Braden score.

All subjects will be included in the trial unless they refuse to participate or are incapacitated to the degree that imaging becomes unreasonable.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Health System
        • Contact:
        • Principal Investigator:
          • Claude S. Burton, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited from Duke North inpatient unit 8100 or 8300. All patients admitted to the above floor will be evaluated for willingness to participate.

Description

Inclusion Criteria:

  • To be admitted to 8100 or 8300 and be willing to participate in the study

Exclusion Criteria:

  • Unwillingness to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Each time a pattern of injury is identified by the device, we will correlate this occurrence with the Braden scale to see whether or not it suggested an injury potential.
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
It is our hypothesis that the pattern of injury will develop without warning from the Braden scores.
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trillennium Medical Imaging, Inc.

Investigators

  • Principal Investigator: Claude S. Burton, M.D., Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ANTICIPATED)

April 1, 2008

Study Completion (ANTICIPATED)

June 1, 2008

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria

April 21, 2008

First Posted (ESTIMATE)

April 22, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2008

Last Update Submitted That Met QC Criteria

April 21, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00003228

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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