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

NCT ID: NCT00664235

Last Updated: 2008-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pressure Ulcers Tissue Injury

Keywords

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Pressure Ulcers Tissue Injury

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unwillingness to participate
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Trillennium Medical Imaging, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Duke University Medical Center

Principal Investigators

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Claude S. Burton, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

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Duke University Health System

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David W Judy, D.O.

Role: CONTACT

Phone: 919-668-0145

Email: [email protected]

Edna E Atwater

Role: CONTACT

Phone: 919-684-5381

Email: [email protected]

Facility Contacts

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David W. Judy, D.O.

Role: primary

Other Identifiers

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Pro00003228

Identifier Type: -

Identifier Source: org_study_id