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Wound Necrosis in Lower Extremity Surgery

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ClinicalTrials.gov Identifier: NCT03351387
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Brandon James Yuan, 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.

Condition or disease Intervention/treatment
Extremity Lower Wounds Combination Product: SPY Intra-operative Angiography

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.

Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Wound Necrosis in Lower Extremity Surgery Using SPY Intra-operative Angiography
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : October 20, 2019
Estimated Study Completion Date : November 20, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
SPY Intra-operative Angiography
The SPY Fluorescent Imaging System
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.




Primary Outcome Measures :
  1. Wound necrosis [ Time Frame: 4 weeks after surgical intervention ]
    Superficial wound necrosis, as evidenced by photography



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
high risk lower extremity surgical candidates
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351387


Contacts
Contact: Nicholas (Nick) Clark, MD 507-284-2511 clark.nicholas@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Nicholas (Nick) Clark, MD         
Principal Investigator: Brandon Yuan, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Brandon Yuan, MD Mayo Clinic

Responsible Party: Brandon James Yuan, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03351387     History of Changes
Other Study ID Numbers: 17-004049
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Brandon James Yuan, Mayo Clinic:
amputation
necrosis
high risk lower extremity wound

Additional relevant MeSH terms:
Wounds and Injuries
Necrosis
Pathologic Processes