An interventional study of Laparotomy and ICG in Laparotomy, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 8 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Treatment
This study is being done to find out if Spectrum Near-Infrared (NIR) imaging with Indocyanine Green (ICG) dye can help measure blood flow around an incision before and after the surgeon closes the incision with staples or sutures.
The Spectrum NIR imaging system uses a handheld camera that produces a special type of light that can help surgeons see things during surgery that are difficult to see with the naked eye, for example, cancer tissue versus healthy tissue. Spectrum NIR imaging has been approved by the Food and Drug Administration (FDA) as a tool that is widely used during surgery.
ICG dye is a sterile solution that can be seen with Spectrum NIR imaging. This dye, used with Spectrum NIR imaging, allows surgeons to see blood flow to parts of the body during and after surgery. Making sure that there is enough blood flow to the surgical site helps to promote a less complicated recovery.
Criteria for Eligibility Prior to Surgery
Inclusion Criteria:
Exclusion Criteria:
Criteria for Eligibility Post-Surgery
Inclusion Criteria:
Subject Exclusion Criteria:
The first 10 patients enrolled will undergo skin closure with staples. The next 10 patients enrolled will undergo skin closure with a running subcuticular suture.to evaluate skin perfusion using the Spectrum NIR imaging system following intravenous injection of ICG in all patients. Patients will be assigned skin closure with either running subcuticular suture or skin staples in a sequential, nonrandomized fashion before the procedure. After the planned surgical procedure is complete, ICG will be injected intravenously. Video of the incision will be recorded. After skin closure is complete, a second intravenous bolus of ICG (same dose as previously injected) will be given. Video of the incision will again be recorded. Measurement of perfusion will subsequently be performed by video analysis at the previously described three predefined points along the incision after surgery is complete and again after skin closure.
Procedure: Laparotomy · Other: ICG · Other: Spectrum NIR imaging system
Laparotomy via vertical midline incision and after the planned surgical procedure is complete.
ICG will be injected intravenously ICG is a fluorescent iodide dye.
The Spectrum NIR imaging system uses a handheld camera that emits light in the NIR range.
percentage of cases with successful perfusion measurements
Feasibility will be determined by the percentage of cases with successful perfusion measurements.
Time frame: 1 year
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center