Wound Necrosis in Lower Extremity Surgery

Extremity Lower Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351387
• Other study ID #: 17-004049
• Status: Completed
• Start date: October 20, 2017
• Est. completion date: April 18, 2018

Study information

• Verified date: December 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 18, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extremity Lower Wounds
• Necrosis
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound necrosis	Superficial wound necrosis, as evidenced by photography	4 weeks after surgical intervention

External Links

•   Mayo Clinic Clinical Trials