Clinical trial NCT03408366: A Study Assessing Circulation Around Surgical Incisions at the Time of Laparotomy Closure
Official title: Feasibility of Assessing Wound Perfusion at the Time of Laparotomy Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparotomy
Keywords: Laparotomy
Surgical Incisions
Wound Perfusion
17-650
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Twenty consecutive patients will be enrolled: the first 10 will have skin closure with staples, and the second 10 will have skin closure with a running subcuticular suture.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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"

Primary outcomes:
measure: percentage of cases with successful perfusion measurements
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memoral Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only )
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memoral Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre (Consent only)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nadeem Abu-Rustum, MD
role: PRINCIPAL_INVESTIGATOR
References: