Feasibility of Assessing Wound Perfusion at the Time of Laparotomy Closure
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Laparotomy
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 20
- Locations
- 8
- Primary Endpoint
- percentage of cases with successful perfusion measurements
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
percentage of cases with successful perfusion measurements
Time Frame: 1 year
Feasibility will be determined by the percentage of cases with successful perfusion measurements.