This pilot trial studies how well spectrum near-infrared imaging with indocyanine green works in assessing circulation around surgical incisions in patients undergoing laparotomy. Spectrum near-infrared imaging uses a camera that produces a special type of light that helps surgeons see things during surgery that are difficult to see with the naked eye. Indocyanine green, a dye that is used with near-infrared imaging, allows surgeons to see blood flow to parts of the body during and after surgery. Diagnostic procedures, such as spectrum near-infrared imaging with indocyanine green, may help measure blood flow around an incision before and after the surgeon closes the incision with staples or sutures.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03408366.
PRIMARY OBJECTIVES:
I. To determine whether measuring abdominal laparotomy incision perfusion is feasible using near-infrared (NIR) imaging before and after incision closure with either running subcuticular suture or skin staples.
SECONDARY OBJECTIVES:
I. To report the incidence of adverse events, such as allergic reactions, associated with indocyanine green (ICG) use and perfusion measurement.
II. Obtain preliminary data to assess the difference in perfusion between the 2 groups.
OUTLINE:
Patients receive ICG dye intravenously (IV) followed by NIR imaging before and after incision closure. The first 10 patients undergo incision closure with the use of staples and the next 10 patients undergo incision closure with the use of subcuticular sutures.
After completion of study treatment, patients are followed up to 30 days.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorNadeem R Abu-Rustum
