NCT00664235

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

Enrollment Period

2 months

First QC Date

April 21, 2008

Last Update Submit

April 21, 2008

Conditions

Keywords

Pressure UlcersTissue Injury

Outcome Measures

Primary Outcomes (1)

  • 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.

    90 days

Secondary Outcomes (1)

  • It is our hypothesis that the pattern of injury will develop without warning from the Braden scores.

    90 days

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Claude S. Burton, M.D.

    Duke Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David W Judy, D.O.

CONTACT

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 21, 2008

First Posted

April 22, 2008

Study Start

February 1, 2008

Primary Completion

April 1, 2008

Study Completion

June 1, 2008

Last Updated

April 22, 2008

Record last verified: 2008-04

Locations