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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Trillennium Medical Imaging, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Trillennium Medical Imaging, Inc.
ClinicalTrials.gov Identifier:
NCT00664235
First received: April 21, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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.


Condition
Pressure Ulcers
Tissue Injury

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Trillennium Medical Imaging, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • It is our hypothesis that the pattern of injury will develop without warning from the Braden scores. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unwillingness to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664235

Contacts
Contact: David W Judy, D.O. 919-668-0145 david.judy@duke.edu
Contact: Edna E Atwater 919-684-5381 atwat004@mc.duke.edu

Locations
United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: David W. Judy, D.O.    919-668-0145    david.judy@duke.edu   
Principal Investigator: Claude S. Burton, M.D.         
Sponsors and Collaborators
Trillennium Medical Imaging, Inc.
Investigators
Principal Investigator: Claude S. Burton, M.D. Duke University Health System
  More Information

No publications provided

Responsible Party: Claude S. Burton, Professor of Medicine, Director Wound Management Institute, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00664235     History of Changes
Other Study ID Numbers: Pro00003228
Study First Received: April 21, 2008
Last Updated: April 21, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Trillennium Medical Imaging, Inc.:
Pressure Ulcers
Tissue Injury

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Wounds and Injuries
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014