NCT03408366

A Study Assessing Circulation Around Surgical Incisions at the Time of Laparotomy Closure

Feasibility of Assessing Wound Perfusion at the Time of Laparotomy Closure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Laparotomy

Interventions

Type	Name	Description
PROCEDURE	Laparotomy	Laparotomy via vertical midline incision and after the planned surgical procedure is complete.
OTHER	ICG	ICG will be injected intravenously ICG is a fluorescent iodide dye.
OTHER	Spectrum NIR imaging system	The Spectrum NIR imaging system uses a handheld camera that emits light in the NIR range.

Timeline

• Start date: 2018-01-15
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2018-01-24
• Last updated: 2022-08-02

Locations

8 sites across 1 country: United States