Intraoperative Evaluation Using ICG and SPY Fluorescence to Prevent Wound Complications in Head and Neck Surgery.

NCT03345732 | Withdrawn

• 1 other identifier: 16-5976
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Wound complications, such as salivary-cutaneous fistulas and skin necrosis, result in significant patient morbidity and death. Head and neck wounds are complicated because of multiple tissue layers, critical structures and variable vascularity. When vascularity is compromised, wounds do not heal and can lead to life threatening haemorrhage or morbid infections. The field of microsurgical reconstruction has developed and expanded over the last 20 years to specifically ameliorate these issues. The challenge is that the vascularity of the microsurgical transplant or the recipient tissue bed can have areas of decreased vascularity that cannot be appreciated by the surgeon's intraoperative exam alone. Surgeons would be able to make better decisions with respect to the vascularity if there was an imaging technique that could indicate the vascular supply of the tissues undergoing surgical reconstruction. Laser-assisted indocyanine green fluorescent dye angiography (LA-ICG) using the SPY System (Novadaq Technologies Inc., Richmond, British Columbia, Canada) is an intraoperative vascular imaging technique that improves the ability of a surgeon to assess the vascular supply in the surgical bed. This tool, which is approved by Health Canada for reconstructive surgery, has been used extensively in breast reconstruction and gastrointestinal procedures with encouraging results. The ability to address ischemic tissues intraoperatively could potentially decrease the rate of devastating wound complications in head and neck surgery patients. The objective of this observational study is to assess the effectiveness of LA-ICG in head and neck reconstructive procedures to reduce the rate of skin necrosis and fistula.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• ICG/SPY system for tissue viability

  To determine how often ICG/SPY system can be used to determine debridement of recipient or donor tissue during head and neck reconstruction

  introperatively

Secondary Outcomes (1)

• Amount of tissue debridement

  intraoperatively

Interventions

ICG and SPY system for wound complications DIAGNOSTIC_TEST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with head and neck cancer requiring surgery.

You may qualify if:

• Adult patients (\>18 years old) who are undergoing reconstruction for traumatic or oncologic head and neck wounds
• Specific defects eligible are any pharyngeal, tracheal, or oral cavity defects at risk of devascularized mucosa, or large skin defects requiring skin advancement flaps. This includes laryngectomy/laryngectomy-partial pharyngectomy with primary closure.
• Patient with the above defects that will be having reconstruction with the following donor tissues: local, regional or autogenous free flaps.
• Informed consent

You may not qualify if:

• Patients who are pregnant or nursing
• Patients with an allergy to iodine (contrast ICG dye contains sodium iodide)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2M9, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 17, 2017
• Study Start: December 8, 2016
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

CA (1)