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

Status:	Recruiting
Healthy:	No
Age Range:	18 - Any
Updated:	3/15/2019
Start Date:	January 15, 2018
End Date:	January 2020
Contact:	Nadeem Abu-Rustum, MD
Email:	abu-rusn@mskcc.org
Phone:	212-639-7051

Feasibility of Assessing Wound Perfusion at the Time of Laparotomy Closure

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:

- Woman undergoing a laparotomy procedure via a vertical midline incision for any
indication with the Gynecology Service at MSK

- Age ≥18 years

Exclusion Criteria:

- Women with hepatic dysfunction as evidenced by elevated transaminases

- Women with a history of cirrhosis or other chronic liver disease

- Women with an allergy to iodine

- Women undergoing laparoscopic or minimally invasive surgery

Criteria for Eligibility Post-Surgery

Inclusion Criteria:

- Woman undergoing a laparotomy procedure via a vertical midline incision for any
indication with the Gynecology Service at MSK

- Age ≥18 years

Subject Exclusion Criteria:

- Women with laparotomy incisions unable to be closed primarily due to tissue or fascial
damage

- Women with transverse laparotomy incisions

- Women with laparotomy incisions left open due to a case classification as
"contaminated" or "dirty"

We found this trial at

sites

Memorial Sloan Kettering Nassau (Consent only)

Uniondale, New York 11553

Phone: 212-639-7051

from

Uniondale, NY