External Wounds Measured for Length by Width Using a Ruler Clinical Trial
Official title:
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.)
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.
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