Perfusion; Complications Clinical Trial
Official title:
Prospective Non-randomized, Non-blinded, Convenience Sample to Evaluate the Surgical Imaging System
This study is designed to evaluate the information provided to the clinicians by the surgical imaging device. It is also to gain insight on the user interface and how "user friendly" it is to the clinician.
Over the last decade, objective ways of measuring tissue oxygen have been introduced into the
medical arena and are being used more and more for assessing ischemic events in tissue.
Handheld Doppler ultrasound, infrared thermography, polarized spectral imaging, laser Doppler
perfusion imaging, and fluorescence imaging have all been used with some degree of success.
However, only a few have gained universal acceptance. [1] Multispectral imaging (MSI) which
uses near-infrared (NIR) light to measure tissue oxygen levels in superficial tissue is
another method that has been successfully used to assess tissue flap health.
The objective of this study is to conduct an evaluation of superficial tissue with
Presygen™/si-1 in various patient types for surgical imaging during breast reconstruction. In
addition, participating surgeons will complete a structured survey regarding their assessment
of Presygen™/si-1 work station during the surgical procedure.
Primary Goal: Evaluation of superficial tissue in various patient types for surgical imaging
during breast reconstruction.
Secondary Goal: Surgeon assessment of surgical work station during surgery through a prepared
questionnaire.
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