Wound Necrosis in Lower Extremity Surgery
- Conditions
- Extremity Lower Wounds
- Interventions
- Combination Product: SPY Intra-operative Angiography
- Registration Number
- NCT03351387
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
-Surgical indication for high risk lower extremity surgery
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SPY Intra-operative Angiography SPY Intra-operative Angiography The SPY Fluorescent Imaging System
- Primary Outcome Measures
Name Time Method Wound necrosis 4 weeks after surgical intervention Superficial wound necrosis, as evidenced by photography
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States