Pilot Study to Assess the Use of Spy Elite for Assessment of Amputation Healing

Wound Healing Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440295
• Other study ID #: 2014-253
• Status: Completed
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: September 2023
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Above Knee Amputation
• Below Knee Amputation
• Lower Extremity Amputation
• Wound Healing

Intervention

Procedure:
• Lower Extremity Amputation

Device:
• SPY Elite Imaging System
The SPY Elite Imaging System is an adjunctive tool that can be used to assess tissue perfusion in real-time and provides surgeons with information that may change their operative plan before leaving the operating room. (http://novadaq.com/products/spy-elite) The system is comprised of two components, the first is the Spy Elite Kit, which is a single-use package containing one 25 mg vial of indocyanine green, one 10 ml vial of sterile Water for injection, and one SPY Elite sterile drape. The second component to the system is the SPY Elite Device which contains a near-infrared light source that illuminates the fluorescent agent within the tissues, an HD video camera captures the intensity of fluorescent marker in real-time, and software that allows the user to capture relative and absolute perfusion values within the surgical field.

Drug:
• Indocyaine Green
Indocyaine Green (ICG) is a non-nephrotoxic fluorescent imaging agent with a half-life of 2.5-3 minutes that is administered intravenously.

Locations

Country	Name	City	State
United States	Spectrum Health Hospitals	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Spectrum Health Hospitals	Novadaq Technologies ULC, now a part of Stryker

Country where clinical trial is conducted

United States, 

References & Publications (4)

Lepow B, Perry D, Armstrong D. The Use of SPY Intra-operative Vascular Angiography as a Predictor of Wound Healing. Podiatry Mgmt. 2011 Aug; 141-148.

Losken A, Zenn MR, Hammel JA, Walsh MW, Carlson GW. Assessment of zonal perfusion using intraoperative angiography during abdominal flap breast reconstruction. Plast Reconstr Surg. 2012 Apr;129(4):618e-624e. doi: 10.1097/PRS.0b013e3182450b16. — View Citation

Pineda C., Shelton A., Raju N., Welton M. Use of Introperative Fluorescence vascular angiography to assess intestinal perfusion in the creation of intestinal anastomoses. Tech Colo. 2011;15:215-253.

Vogel TR, Petroski GF, Kruse RL. Impact of amputation level and comorbidities on functional status of nursing home residents after lower extremity amputation. J Vasc Surg. 2014 May;59(5):1323-30.e1. doi: 10.1016/j.jvs.2013.11.076. Epub 2014 Jan 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Healing Post Lower Extremity Amputation	The primary outcome variable includes wound healing at 30 days and intra-operative imaging of amputation sites using the SPY Elite System.	30 days post
Secondary	Level of Amputation	The secondary outcome variables include level of amputation.	Intra-operative
Secondary	Wound Healing	The secondary outcome variables include 30-day wound healing complications.	30 days Post Lower Extremity Amputation
Secondary	Readmission Rates	The secondary outcome variables include readmission rates.	30 days Post Lower Extremity Amputation
Secondary	Lower Extremity Amputation Revision	The secondary outcome variables include need for revision.	30 days Post Lower Extremity Amputation
Secondary	Subject Demographics	The secondary outcome variables include subject demographics	Participants will be followed for the duration of the hospital stay and 30 days post lower extremity amputation
Secondary	Co-morbidities	The secondary outcome variables include co-morbidites.	Participants will be followed for the duration of the hospital stay and 30 days post lower extremity amputation

External Links

•   Spy Elite System Overview