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Wound Necrosis in Lower Extremity Surgery

NCT03351387 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2021-12-17

No results posted yet for this study

Summary

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.

Conditions

  • Extremity Lower Wounds

Interventions

COMBINATION_PRODUCT

SPY Intra-operative Angiography

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.

Sponsors & Collaborators

Principal Investigators

  • Brandon Yuan, MD · Mayo Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-20
Primary Completion
2018-04-18
Completion
2018-04-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03351387 on ClinicalTrials.gov