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

Not Applicable

Completed

• Conditions: Laparotomy
• Interventions: Procedure: Laparotomy; Other: ICG; Other: Spectrum NIR imaging system

• Registration Number: NCT03408366
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-24
• Status Verified: 2022-08
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Woman undergoing a laparotomy procedure via a vertical midline incision for any indication with the Gynecology Service at MSK
• Age ≥18 years

Read More

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"

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Women having a Laparotomy	Laparotomy	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.
Women having a Laparotomy	ICG	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.
Women having a Laparotomy	Spectrum NIR imaging system	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.

Primary Outcome Measures

Name	Time	Method
percentage of cases with successful perfusion measurements	1 year	Feasibility will be determined by the percentage of cases with successful perfusion measurements.

Trial Locations

Locations (8)

Memoral Sloan Kettering Monmouth (Consent only); 🇺🇸 Middletown, New Jersey, United States

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

Memorial Sloan Kettering Bergen (Consent only ); 🇺🇸 Montvale, 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

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, United States