LaparotomyNCT03408366
A Study Assessing Circulation Around Surgical Incisions at the Time of Laparotomy Closure
A study testing Laparotomy, ICG and Spectrum NIR imaging system in people with Laparotomy, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Laparotomy
- What is being tested?
- Laparotomy, ICG and Spectrum NIR imaging system
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesUnited States
- Study dates
- 15 Jan 2018to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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"
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Memoral Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, 11725
Memoral Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604
Memoral Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Rockville Centre (Consent only)
Rockville Centre, New York, 11570
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, 11553
About this study
Official title: Feasibility of Assessing Wound Perfusion at the Time of Laparotomy Closure
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
- Being tested
- Laparotomy, ICG, Spectrum NIR imaging system
- Keywords
- Laparotomy, Surgical Incisions, Wound Perfusion, 17-650
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparotomyProcedure or surgery
Laparotomy via vertical midline incision and after the planned surgical procedure is complete.
ICGOther
ICG will be injected intravenously ICG is a fluorescent iodide dye.
Spectrum NIR imaging systemOther
The Spectrum NIR imaging system uses a handheld camera that emits light in the NIR range.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Laparotomy; Other: ICG; Other: Spectrum NIR imaging system |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of cases with successful perfusion measurements
Feasibility will be determined by the percentage of cases with successful perfusion measurements.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start15 Jan 2018
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparotomyStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadeem Abu-Rustum, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408366
- Sponsor's protocol ID
- 17-650
- Status last verified
- Aug 2022
- First submitted
- 17 Jan 2018
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Assessing Wound Perfusion at the Time of Laparotomy Closure
- ClinicalTrials.gov ID
- NCT03408366
- Acronym / sponsor ID
- 17-650
- Conditions
- Laparotomy
- Keywords
- Laparotomy, Surgical Incisions, Wound Perfusion, 17-650
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Women having a Laparotomy | Experimental | Procedure: Laparotomy, Other: ICG, Other: Spectrum NIR imaging systemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Women with laparotomy incisions unable to be closed primarily due to tissue or fascial damage
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaparotomyLaparotomy via vertical midline incision and after the planned surgical procedure is complete. | Procedure or surgery | Women having a Laparotomy |
| ICGICG will be injected intravenously ICG is a fluorescent iodide dye. | Other | Women having a Laparotomy |
| Spectrum NIR imaging systemThe Spectrum NIR imaging system uses a handheld camera that emits light in the NIR range. | Other | Women having a Laparotomy |
Primary outcome
percentage of cases with successful perfusion measurements
Time frame: 1 year
Feasibility will be determined by the percentage of cases with successful perfusion measurements.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadeem Abu-Rustum, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparotomy, ICG and Spectrum NIR imaging system in people with Laparotomy, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of cases with successful perfusion measurements (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.