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

Primary Purpose

Laparotomy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparotomy
ICG
Spectrum NIR imaging system
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparotomy focused on measuring Laparotomy, Surgical Incisions, Wound Perfusion, 17-650

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Criteria for Eligibility Prior to 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

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"

Sites / Locations

  • Memoral Sloan Kettering Basking Ridge (Consent only)
  • Memoral Sloan Kettering Monmouth (Consent only)
  • Memorial Sloan Kettering Bergen (Consent only )
  • Memorial Sloan Kettering Commack (Consent only)
  • Memoral Sloan Kettering Westchester (Consent only)
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Rockville Centre (Consent only)
  • Memorial Sloan Kettering Nassau (Consent only)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Women having a Laparotomy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 17, 2018
Last Updated
August 1, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03408366
Brief Title
A Study Assessing Circulation Around Surgical Incisions at the Time of Laparotomy Closure
Official Title
Feasibility of Assessing Wound Perfusion at the Time of Laparotomy Closure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparotomy
Keywords
Laparotomy, Surgical Incisions, Wound Perfusion, 17-650

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Women having a Laparotomy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparotomy
Intervention Description
Laparotomy via vertical midline incision and after the planned surgical procedure is complete.
Intervention Type
Other
Intervention Name(s)
ICG
Intervention Description
ICG will be injected intravenously ICG is a fluorescent iodide dye.
Intervention Type
Other
Intervention Name(s)
Spectrum NIR imaging system
Intervention Description
The Spectrum NIR imaging system uses a handheld camera that emits light in the NIR range.
Primary Outcome Measure Information:
Title
percentage of cases with successful perfusion measurements
Description
Feasibility will be determined by the percentage of cases with successful perfusion measurements.
Time Frame
1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Woman undergoing a laparotomy procedure
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Criteria for Eligibility Prior to 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 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"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadeem Abu-Rustum, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memoral Sloan Kettering Basking Ridge (Consent only)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memoral Sloan Kettering Monmouth (Consent only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen (Consent only )
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack (Consent only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memoral Sloan Kettering Westchester (Consent only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Rockville Centre (Consent only)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Memorial Sloan Kettering Nassau (Consent only)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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

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