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NCT03408366 Clinical Trial

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

Laparotomy Clinical Trial

Official title:
Feasibility of Assessing Wound Perfusion at the Time of Laparotomy Closure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03408366
Other study ID # 17-650
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2018
Est. completion date August 1, 2022

Study information
Verified date August 2022
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date August 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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"

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Memoral Sloan Kettering Basking Ridge (Consent only) Basking Ridge 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 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 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

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary percentage of cases with successful perfusion measurements Feasibility will be determined by the percentage of cases with successful perfusion measurements. 1 year
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