Wound Necrosis in Lower Extremity Surgery

Mayo Clinic

Status: Completed

Conditions: Extremity Lower Wounds

Treatments: Combination Product: SPY Intra-operative Angiography

Study type: Observational

Funder types: Other

Identifiers

NCT03351387

17-004049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

SPY Intra-operative Angiography

Description:

The SPY Fluorescent Imaging System

Treatment:

Combination Product: SPY Intra-operative Angiography