Deep View Study

Summary

Design: United States, UT Southwestern Medical Center at Dallas, Observational study

Population: Approximately 100 inpatients will take part in this study at UT Southwestern Medical Center at Dallas. One hundred patients are required to observe an array of wound etiologies to evaluate performance of the imager under different clinical scenarios.

Randomization and Blinding: Physicians and investigators processing and analyzing results will not be blinded from subject data and medical history.

Subjects will be imaged during regular 30-minute sessions for a period of up to three months. The device itself works similarly to a regular camera. The device will not contact the patient, and individuals who use the device will be properly trained on its safe use by the device[Right Quote]s designers. Additional analysis of the device[Right Quote]s safety has demonstrated that it may be used without posing significant risk to patients or operators. Sessions may increase in frequency up to 3 times in a week, dependent on the rate of change in tissue state or severity of injury. In addition to assessing tissue state at a single time point, this study aims to assess time-dependent changes in tissue morphology and pathology.

The imaging will be conducted in regions most susceptible to nosocomial wounds, such as decubitus ulcers. This would include areas such as the feet, hands, spine, and sacrum. Additionally, wound assessment may be performed on areas such as the chest, after skin flaps. The safety of the device does not limit possible locations of imaging. Thus, all areas that have sustained wounds or present risk factors for such a condition may be studied.

The results being assessed by physicians will be a spatiotemporal color map of the region of interest. The image will convey the activity level of blood pulsing through the region of interest, allowing an evaluation of correlation between the mapped image and the clinical condition of the patient.

Participant Eligibility

1. 18+ years of age.
2. Currently admitted or will be admitted in hospital following cardiothoracic procedure.
3a. Presence of wounds.

* No wound size would be excluded.
3b. Presence of potential risk factors that may lead to wound development.

* Risk factors include poor circulation, mechanical stress of tissue, temperature, moisture, infection, medications, nutrition, disease, age and body type.

* Wounds that satisfy the inclusion criteria include wounds from skin flaps, wounds from burns, nosocomial wounding or decubitus ulcers, as well as diabetic feet and cases of peripheral vascular insufficiency and disease.