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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Laparotomy

Treatments: Other: Spectrum NIR imaging system; Procedure: Laparotomy; Other: ICG

Study type: Interventional

Funder types: Other

Identifiers

NCT03408366

17-650

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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"

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Women having a Laparotomy

Experimental group

Description:

The first 10 patients enrolled will undergo skin closure with staples. The next 10 patients enrolled will undergo skin closure with a running subcuticular suture.to evaluate skin perfusion using the Spectrum NIR imaging system following intravenous injection of ICG in all patients. Patients will be assigned skin closure with either running subcuticular suture or skin staples in a sequential, nonrandomized fashion before the procedure. After the planned surgical procedure is complete, ICG will be injected intravenously. Video of the incision will be recorded. After skin closure is complete, a second intravenous bolus of ICG (same dose as previously injected) will be given. Video of the incision will again be recorded. Measurement of perfusion will subsequently be performed by video analysis at the previously described three predefined points along the incision after surgery is complete and again after skin closure.

Treatment:

Procedure: Laparotomy

Other: ICG

Other: Spectrum NIR imaging system