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ICG for Laparotomy
N/A
Waitlist Available
Led By Nadeem Abu-Rustum, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Criteria for Eligibility Prior to Surgery
Woman undergoing a laparotomy procedure via a vertical midline incision for any indication with the Gynecology Service at MSK
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will use Spectrum NIR imaging with ICG dye to see if it can help surgeons measure blood flow around an incision before and after the surgeon closes the incision.
Eligible Conditions
- Laparotomy
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
percentage of cases with successful perfusion measurements
Trial Design
1Treatment groups
Experimental Treatment
Group I: Women having a LaparotomyExperimental Treatment3 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Laparotomy
2010
Completed Phase 4
~1000
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,362 Total Patients Enrolled
Nadeem Abu-Rustum, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
1,608 Total Patients Enrolled
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