Wound Necrosis in Lower Extremity Surgery

Study Overview
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Brief Summary
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Researchers are performing this study to evaluate if intraoperative angiography can be shown numerically to determine which wounds are at high risk of wound necrosis/breakdown.

Detailed Description
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At the beginning of the Participants surgical procedure, a picture will be obtained using intraoperative angiography using ICG dye which the camera can detect. This dye will be provided through intravenous access. The picture will be taken of the wound to determine preoperative blood flow to the area where the incision is planned. After the wound has been closed postoperatively, a final picture, using the procedure described above, will be taken to determine blood flow after closure of the wound. These images will be obtained using intraoperative angiography. The Participant will be followed after the surgical procedure at standard intervals as determined by the surgeon until the wound heals or requires further intervention.

Official Title
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Assessment of Wound Necrosis in Lower Extremity Surgery Using SPY Intra-operative Angiography

Conditions
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Extremity Lower Wounds

Intervention / Treatment
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* Combination Product: SPY Intra-operative Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Surgical indication for high risk lower extremity surgery Exclusion Criteria: Previous high risk lower extremity surgery Revision high risk lower extremity surgery Traumatic amputation Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SPY Intra-operative Angiography<br>The SPY Fluorescent Imaging System | Combination Product: SPY Intra-operative Angiography<br>* The SPY Intra-operative Angiography Fluorescent Imaging System consists of an imaging head equipped with a charged coupled device (CCD) camera, a laser light source and a distance sensor. The imaging head is attached to an articulating arm on a mobile cart containing the central processing unit, keyboard, monitor, and mouse. SPY is used in tandem with indocyanine green (ICG), a water-soluble tricarbocyanine dye. Once the camera is in place, 5 cc of diluted ICG is pushed through an IV line and is flushed immediately; simultaneously the room lights must be dimmed. Perfusion images will be recorded then the SPY system will be removed from the operating room.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound necrosis | Superficial wound necrosis, as evidenced by photography | 4 weeks after surgical intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amputation, necrosis, high risk lower extremity wound