Pilot Study to Assess the Use of Spy Elite for Assessment of Amputation Healing
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2016 |
| Start Date: | May 2015 |
| End Date: | December 2016 |
| Contact: | Monica J. Rudy, RN |
| Email: | Monica.Rudy@spectrumhealth.org |
| Phone: | 616-391-0556 |
The purpose of the study is to evaluate the use of the SPY Elite System to assess real-time
tissue perfusion of lower extremity amputation sites and to develop parameters to predict
healing of amputations at the time of surgery.
This is a pilot study to see if the Spy Elite System is capable of recording accurate
measurements on amputation sites to allow some correlation to healing. If this study shows
promise for the device, the investigators would plan a larger study in which the data would
be assessed in the operating room at time of acquisition and revision performed if needed
based on the findings.
tissue perfusion of lower extremity amputation sites and to develop parameters to predict
healing of amputations at the time of surgery.
This is a pilot study to see if the Spy Elite System is capable of recording accurate
measurements on amputation sites to allow some correlation to healing. If this study shows
promise for the device, the investigators would plan a larger study in which the data would
be assessed in the operating room at time of acquisition and revision performed if needed
based on the findings.
The pilot study is a prospective cohort study of consented subjects who require below knee
or above knee amputation. The study will start with 18 subjects to assess proof of concept.
If a correlation is identified, then a new proposal will be submitted with a larger cohort.
Our hypothesis is that the Spy Elite System can help identify areas of poor tissue perfusion
at the time of lower extremity amputation, and predict future potential wound healing
complications.
Primary outcome variables include wound healing at 30 days, and intra-operative imaging of
amputation sites using the Spy Elite System. Secondary outcome variables include level of
amputation, 30-day wound healing complications, readmission rate, need for revision, and
subject demographics and co-morbidities.
Subjects who agree to participation will undergo the amputations in the operating suite as
per routine. The Spy Elite System will be implemented after final wound closure and prior to
dressing placement. A single injection of 10 mg of Indocyanine Green will be administered,
followed by 10 ml bolus of normal saline as per manufacturer IFU and recommendations
(Attachments B, C, D). Recording from the Spy Elite Device will be saved for analysis. Also,
a digital photograph of the surgical wound will be saved for comparison. No changes in
operative management based on Spy Elite System will take place in this study.
At subjects routine 30-day follow up appointment, wounds will be assessed for complications,
a digital photograph of the incision will be saved, and secondary endpoints will be
obtained.
Possible correlations between perfusion values from the Spy Elite System recording and wound
healing will be analyzed by the Investigators. The values will not be known until after the
photos are taken and the investigators compare ischemic areas to normal areas based on the
collected photographs.
or above knee amputation. The study will start with 18 subjects to assess proof of concept.
If a correlation is identified, then a new proposal will be submitted with a larger cohort.
Our hypothesis is that the Spy Elite System can help identify areas of poor tissue perfusion
at the time of lower extremity amputation, and predict future potential wound healing
complications.
Primary outcome variables include wound healing at 30 days, and intra-operative imaging of
amputation sites using the Spy Elite System. Secondary outcome variables include level of
amputation, 30-day wound healing complications, readmission rate, need for revision, and
subject demographics and co-morbidities.
Subjects who agree to participation will undergo the amputations in the operating suite as
per routine. The Spy Elite System will be implemented after final wound closure and prior to
dressing placement. A single injection of 10 mg of Indocyanine Green will be administered,
followed by 10 ml bolus of normal saline as per manufacturer IFU and recommendations
(Attachments B, C, D). Recording from the Spy Elite Device will be saved for analysis. Also,
a digital photograph of the surgical wound will be saved for comparison. No changes in
operative management based on Spy Elite System will take place in this study.
At subjects routine 30-day follow up appointment, wounds will be assessed for complications,
a digital photograph of the incision will be saved, and secondary endpoints will be
obtained.
Possible correlations between perfusion values from the Spy Elite System recording and wound
healing will be analyzed by the Investigators. The values will not be known until after the
photos are taken and the investigators compare ischemic areas to normal areas based on the
collected photographs.
Inclusion Criteria:
- All patients >= 18 years of age requiring Below Knee Amputation (BKA) or Above Knee
Amputation (AKA) cared for by the vascular surgery service will be assessed for
eligibility.
Exclusion Criteria:
- Subjects with a history of allergies to iodides or iodinated contrast agents,
pregnant or nursing women, subjects who are unable to provide consent, and prisoners
will be excluded.
We found this trial at
1
site
Grand Rapids, Michigan 49503
Principal Investigator: Robert F. Cuff, MD
Phone: 616-391-0556
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