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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2022-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Laparotomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Women having a 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.

Group Type EXPERIMENTAL

Laparotomy

Intervention Type PROCEDURE

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

ICG

Intervention Type OTHER

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

Spectrum NIR imaging system

Intervention Type OTHER

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

Interventions

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Laparotomy

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

Intervention Type PROCEDURE

ICG

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

Intervention Type OTHER

Spectrum NIR imaging system

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

* 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

* 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"

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No