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Completed

NCT Number: NCT03351387

Wound Necrosis in Lower Extremity Surgery

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.

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Key information

Conditions

Extremity Lower Wounds Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPY Intra-operative Angiography

Combination Product

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.

Primary outcomes

  1. Wound necrosis

    Time frame: 4 weeks after surgical intervention

    Superficial wound necrosis, as evidenced by photography

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 22, 2017
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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