Overlaying a Visual Wound Trace Onto Its Thermal Image in a Wound Clinic

WoundVision

Status: Completed

Conditions: Wounds and Injuries

Treatments: Device: ImageReview's unaffected reference area selected; Device: ImageReview's External Wound Trace Overlay; Device: ImageReview's visual perimeter trace of the external wound; Device: Adjacent tissue trace of the wound trace overlay; Device: Scout takes visual and thermal images of external wounds

Study type: Interventional

Funder types: Industry

Identifiers

NCT02028390

WV13CL-0008 Revision 02

Details and patient eligibility

About

The purpose of this study is to test and evaluate how well a medical imaging device that takes both visual and thermal pictures of wounds or body surface areas of interest can help collect added information about the wounds or body surface areas of interest in a wound clinic.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or greater, of either gender and of any ethnic background

• Able to tolerate position change(s) and turns for up to 10 minutes comfortably

• Have an existing external wound or body surface area of interest:

  • External wound or body surface area of interest 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 or body surface area of interest:

  • External wound or body surface area of interest that fits entirely within the field of view and does not wrap around a body edge
  • No device or treatment will obscure the external wound or body surface area of interest

Exclusion criteria

• Neonatal and pediatric patients

• Pregnant women

• Cannot tolerate position changes for up to 10 minutes comfortably (per external wound site imaged)

• On therapies or treatments which cannot be safely suspended long enough to conduct an imaging session as determined by facility policy

• Have a 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.

• If the patient has a complex external wound:

  • The external wound wraps around a body edge or otherwise cannot be imaged entirely within the visual field of view.
  • From visual assessment, the external wound edges are not definable and/or cannot be clearly distinguished from other conditions near external wound (E.g. breakdown or the deterioration of the surrounding body surfaces due to other conditions such as cancer or other types of ulcers makes determining the edge of the external wound impossible).

• Have not provided signed informed consent

• Non-English speaking

• Subjects in isolation

Trial design

31 participants in 1 patient group

subjects with external wounds

Experimental group

Description:

Subjects with external wounds or body surface areas of interest are imaged visually and thermally with the Scout to trace the wound's perimeter visually and measure thermal variation data as described in the primary outcomes, using the ImageReview software.

Treatment:

Device: Scout takes visual and thermal images of external wounds

Device: ImageReview's unaffected reference area selected

Device: ImageReview's visual perimeter trace of the external wound

Device: ImageReview's External Wound Trace Overlay

Device: Adjacent tissue trace of the wound trace overlay