MedTrace Logo

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

NCT03408366 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-08-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Nadeem Abu-Rustum, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2022-08-01
Completion
2022-08-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03408366 on ClinicalTrials.gov