Measuring Wounds Found on the Outside of the Body Surface
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/8/2017 |
| Start Date: | May 2013 |
| End Date: | December 2013 |
Utilizing Visual and Thermal Images for the Measuring and Monitoring of External Wounds
The purpose of this study is to test wounds found on the outside of the body surface with an
investigational medical imaging device that collects visual pictures and thermal digital
pictures of the wound site. The investigational device has not been approved by the Food and
Drug Administration (FDA).
The medical imaging device is non-contacting and is non-radiating (delivers no energy to the
body). It passively collects pictures (typical digital color photographs)and thermal pictures
(black and white digital photographs of heat at the body surface.)
investigational medical imaging device that collects visual pictures and thermal digital
pictures of the wound site. The investigational device has not been approved by the Food and
Drug Administration (FDA).
The medical imaging device is non-contacting and is non-radiating (delivers no energy to the
body). It passively collects pictures (typical digital color photographs)and thermal pictures
(black and white digital photographs of heat at the body surface.)
This prospective study utilizes the WoundVision Wound Measuring and Monitoring System (WMMS)
to study external wounds, which can currently be measured for length by width using a ruler.
WMMS operates by taking simultaneous visual and thermal images of the external wound site and
the associated body surface. These images are evaluated by utilizing the WMMS ImageReview
measuring and monitoring software. WMMS ImageReview software allows for LxW (length by width)
and surface area (cm squared),as well as perimeter (cm) external wound measurements of the
visual image. WMMS ImageReview software also allows for the display of thermal intensity
variation data for the associated body surface of the corresponding thermal image.
This study is primarily designed to utilize the Coefficients of Individual Agreement (CIA)as
a means of establishing the equivalence of area measurements utilizing the WMMS ImageReview
software LxW technique and the current "gold standard" LxW manual ruler technique.
A secondary objective measures the thermal intensity variation data of the external wound bed
by overlaying the corresponding "Visual External Wound Trace"from the visual image onto the
thermal wound bed.
to study external wounds, which can currently be measured for length by width using a ruler.
WMMS operates by taking simultaneous visual and thermal images of the external wound site and
the associated body surface. These images are evaluated by utilizing the WMMS ImageReview
measuring and monitoring software. WMMS ImageReview software allows for LxW (length by width)
and surface area (cm squared),as well as perimeter (cm) external wound measurements of the
visual image. WMMS ImageReview software also allows for the display of thermal intensity
variation data for the associated body surface of the corresponding thermal image.
This study is primarily designed to utilize the Coefficients of Individual Agreement (CIA)as
a means of establishing the equivalence of area measurements utilizing the WMMS ImageReview
software LxW technique and the current "gold standard" LxW manual ruler technique.
A secondary objective measures the thermal intensity variation data of the external wound bed
by overlaying the corresponding "Visual External Wound Trace"from the visual image onto the
thermal wound bed.
Inclusion Criteria:
- Age 18 or greater, of either gender and of any ethnic background
- Able to tolerate position changes and turns for up to 10 minutes comfortably
- Have an existing external wound that is currently measured for length and width using
a ruler
- The protocol will allow imaging up to 3 external wounds per subject
- The 3 external wounds must be in separate body locations (ex: one on the right
heel, one on the left heel, and the other on the sacrum).
- Have qualifying external wound sites:
- External wounds whose external wound site fits entirely within the field of view
and do not wrap around a body edge.
- No device or treatment will obscure the external wound site
Exclusion Criteria:
- Neonatal and pediatric patients
- Pregnant women
- Cannot tolerate position changes for up to 10 minutes comfortably (per external wound
site imaged)
- Cannot be positioned so images can be taken at approximately 90 degrees perpendicular
and 18 inches away from the external wound site
- On therapies or treatments which cannot be safely suspended long enough to conduct an
imaging session as determined by facility policy
- Have external wound dressing or medical device which cannot or should not be removed
as determined by site investigator
- Have an external wound with excessive or heavy exudate that cannot be controlled
during the imaging session. Excessive drainage can obscure external wound features
- Have complex external wound site(s):
- The external wound wraps around a body edge or otherwise cannot be imaged
entirely within the visual field of view
- From visual assessment the existing external wound cannot be clearly
distinguished from other conditions at the external wound site (e.g. break down
or the deterioration of the surrounding body surfaces due to other conditions
such as cancer or other types of wounds makes determining the edge of the
external wound impossible)
- Have not provided signed informed consent
- Non-English speaking
We found this trial at
2
sites
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