A Study Assessing Circulation Around Surgical Incisions at the Time of Laparotomy Closure
Completed · Not applicable
Conditions studied: Laparotomy
In brief
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.
Key facts
- Study ID
- NCT03408366
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 20
- Starts
- 2018-01-15
- Expected to finish
- 2022-08-01
- Last updated by the study team
- 2022-08-02
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Woman undergoing a laparotomy procedure via a vertical midline incision for any indication with the Gynecology Service at MSK
- Age ≥18 years
You may not qualify if…
- 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"
Where it is running
- Memoral Sloan Kettering Basking Ridge (Consent only) — Basking Ridge, New Jersey, United States
- Memoral Sloan Kettering Monmouth (Consent only) — Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen (Consent only ) — Montvale, New Jersey, United States
- Memorial Sloan Kettering Commack (Consent only) — Commack, New York, United States
- Memoral Sloan Kettering Westchester (Consent only) — Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Memorial Sloan Kettering Rockville Centre (Consent only) — Rockville Centre, New York, United States
- Memorial Sloan Kettering Nassau (Consent only) — Uniondale, New York, United States
Full record on ClinicalTrials.gov
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