An interventional study of Laparotomy and ICG in Laparotomy, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 8 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Treatment
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Among 129 studies in Surgical Wound with a site in United States — 17 open to participants now, 21 under way, none of them phase 3. Surgical Wound · United States.
Among the 129 studies in Surgical Wound with a site in United States, this one is the 82nd largest by enrollment of the 111 interventional ones that give a count, is one of 12 that started in 2018, is one of 88 with no phase, and was the 51st registered.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
Browse Surgical Wound studies →17 of the 129 studies in Surgical Wound with a site in United States are open now. Recruiting first, the newest first:
The Metis Foundation · Sites in United States
Ages 18–85
Acera Surgical, Inc. · Sites in United States
Ages 18+
University of Nevada, Las Vegas · Sites in United States
Ages 18+ · Healthy volunteers
Hospital for Special Surgery, New York · Sites in United States
Ages 18+
Venus Concept · Sites in United States
Ages 21–75 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 33 Surgical Wound studies recruiting now, 19 (58%) set no upper age limit and 10 (30%) stop at 75 or younger; 6 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
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129 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 5 · Phase 3 4 · Phase 4 11
First in 2004; this study’s year is marked. 12 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 66 across 242 interventional studies indexed under Surgical Wound.
Median enrollment 50 across the 111 interventional studies, 46 across the 18 observational. Of the 87 that completed or were terminated, 43 (49%) have results posted.
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45 of 129 have an industry lead sponsor. The 10 most frequent:
Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.
Memorial Sloan Kettering Cancer Center has 1 study filed under Surgical Wound — fewer than ten, so there is no comparison to draw.
9 of the studies in Surgical Wound with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06259409Progenerative Medical, IncRegenn® Therapy System Safety Study | 2026-12 |
| NCT04718168W.L.Gore & AssociatesGORE® ENFORM Biomaterial Product Study | 2026-12 |
| NCT06014411Hospital for Special Surgery, New YorkEarly Versus Delayed Bathing of Orthopaedic Surgical Wounds | 2026-12 |
| NCT07653165West Boca Center for Wound HealingUse of Hydroprep Wound Therapy With Motion Negative Pressure Therapy for Treatment of Chronic Lower Extremity Wounds | 2026-12-31 |
| NCT04786106Charitable Union for the Research and Education of Peyronie's DiseaseInvestigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's | 2027-02-15 |
Add all 9 to your calendar (.ics) → With an account.
Among the 129 studies in Surgical Wound with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Criteria for Eligibility Prior to Surgery
Inclusion Criteria:
Exclusion Criteria:
Criteria for Eligibility Post-Surgery
Inclusion Criteria:
Subject Exclusion Criteria:
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.
Procedure: Laparotomy · Other: ICG · Other: Spectrum NIR imaging system
Laparotomy via vertical midline incision and after the planned surgical procedure is complete.
ICG will be injected intravenously ICG is a fluorescent iodide dye.
The Spectrum NIR imaging system uses a handheld camera that emits light in the NIR range.
percentage of cases with successful perfusion measurements
Feasibility will be determined by the percentage of cases with successful perfusion measurements.
Time frame: 1 year
Ran from Jan 2018 to primary completion in Aug 2022, 54 months.
Of 99 non-industry interventional studies with no phase under Surgical Wound, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 53. This study's 54 months is above that.
Counting every sponsor, half of 126 studies reached it within 18 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center →