Completed

NCT Number: NCT03408366

A Study Assessing Circulation Around Surgical Incisions 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.

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Key information

Conditions

Laparotomy Surgical Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Memoral Sloan Kettering Basking Ridge (Consent only), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

Laparotomy

Procedure

Laparotomy via vertical midline incision and after the planned surgical procedure is complete.

ICG

Other

ICG will be injected intravenously ICG is a fluorescent iodide dye.

Spectrum NIR imaging system

Other

The Spectrum NIR imaging system uses a handheld camera that emits light in the NIR range.

Primary outcomes

percentage of cases with successful perfusion measurements

Time frame: 1 year

Feasibility will be determined by the percentage of cases with successful perfusion measurements.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Feasibility of Assessing Wound Perfusion at the Time of Laparotomy Closure

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Jan 24, 2018
Registry last updated: Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed