Pressure Ulcers Clinical Trial
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
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.
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.
;
Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02930590 -
Effects of Different Support Surfaces on the Properties Skin After Loading
|
N/A | |
Completed |
NCT02224404 -
Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended
|
N/A | |
Completed |
NCT01965444 -
A Test of the Investigational SEM Scanner
|
N/A | |
Withdrawn |
NCT00623948 -
Implanted Gluteal Stimulation System for Pressure Sore Prevention
|
N/A | |
Terminated |
NCT01433159 -
Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
|
Phase 2 | |
Recruiting |
NCT01355666 -
Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
|
N/A | |
Completed |
NCT01403272 -
Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
|
N/A | |
Completed |
NCT00971048 -
Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
|
N/A | |
Completed |
NCT01008254 -
Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers
|
Phase 2/Phase 3 | |
Terminated |
NCT00762138 -
The AutoloGelâ„¢ Post-Market Surveillance (TAPS) Program
|
N/A | |
Completed |
NCT00507650 -
Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers
|
N/A | |
Completed |
NCT01877681 -
Reference Nurse Program for Pressure Ulcers in Primary Care
|
Phase 2 | |
Completed |
NCT01232764 -
Pressure Ulcer Multi-disciplinary Teams Via Telemedicine (PUMTT): A Trial in Long Term Care
|
Phase 3 | |
Completed |
NCT06374563 -
Tackling Pressure Ulcer Via Bee Venom Phonophoresis
|
N/A | |
Completed |
NCT03070925 -
Prospective PuraPlyâ„¢ AM Case Series Study
|
N/A | |
Completed |
NCT02894437 -
Qualitative Study of Preventive Organization of the Pelvic Bedsores Injured Spinal Cord
|
||
Completed |
NCT01348581 -
Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing
|
N/A | |
Completed |
NCT00763282 -
Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)
|
N/A | |
Completed |
NCT00771238 -
Pilot Study of Incidence and Change in Existing Pressure Ulcers: TC500 Bed Compared With Standard Beds
|
N/A | |
Completed |
NCT01885962 -
Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers
|
N/A |