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

NCT03408366 | Completed

• 1 other identifier: 17-650
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 8

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.

Conditions

Laparotomy

Keywords

Laparotomy; Surgical Incisions; Wound Perfusion; 17-650

Outcome Measures

Primary Outcomes (1)

• percentage of cases with successful perfusion measurements

  Feasibility will be determined by the percentage of cases with successful perfusion measurements.

  1 year

Study Arms (1)

Women having a Laparotomy

EXPERIMENTAL

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.

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

Interventions

Laparotomy PROCEDURE

Laparotomy via vertical midline incision and after the planned surgical procedure is complete.

Women having a Laparotomy

ICG OTHER

ICG will be injected intravenously ICG is a fluorescent iodide dye.

Women having a Laparotomy

Spectrum NIR imaging system OTHER

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

Women having a Laparotomy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Woman undergoing a laparotomy procedure
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (8)

Memoral Sloan Kettering Basking Ridge (Consent only)

Basking Ridge, New Jersey, 07920, United States

Location

Memoral Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent only )

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, 11725, United States

Location

Memoral Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre (Consent only)

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Nassau (Consent only)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Surgical Wound

Interventions

Laparotomy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Nadeem Abu-Rustum, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 24, 2018
• Study Start: January 15, 2018
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-08

Locations

US (8)