Extremity Lower Wounds
Conditions
Keywords
amputation, necrosis, high risk lower extremity wound
Brief 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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTSPY 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
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound necrosis | 4 weeks after surgical intervention | Superficial wound necrosis, as evidenced by photography |
Countries
United States
Outcome results
None listed