NCT03351387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2018

Completed
Last Updated

December 17, 2021

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

November 20, 2017

Last Update Submit

December 15, 2021

Conditions

Extremity Lower Wounds

Keywords

amputationnecrosishigh risk lower extremity wound

Outcome Measures

Primary Outcomes (1)

  • Wound necrosis

    Superficial wound necrosis, as evidenced by photography

    4 weeks after surgical intervention

Study Arms (1)

SPY Intra-operative Angiography

The SPY Fluorescent Imaging System

Combination Product: SPY Intra-operative Angiography

Interventions

SPY Intra-operative AngiographyCOMBINATION_PRODUCT

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.

SPY Intra-operative Angiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

high risk lower extremity surgical candidates

You may qualify if:

  • Surgical indication for high risk lower extremity surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Necrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Brandon Yuan, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 22, 2017

Study Start

October 20, 2017

Primary Completion

April 18, 2018

Study Completion

April 18, 2018

Last Updated

December 17, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)