Status:
WITHDRAWN
Intraoperative Evaluation Using ICG and SPY Fluorescence to Prevent Wound Complications in Head and Neck Surgery.
Lead Sponsor:
University Health Network, Toronto
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
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, c...
Detailed Description
This is a prospective, observational study in patients undergoing head and neck surgery with reconstruction. Patients will be identified preoperatively by the participating surgeons. Eligible patients...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients who are pregnant or nursing
- Patients with an allergy to iodine (contrast ICG dye contains sodium iodide)
Key Trial Info
Start Date :
December 8 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03345732
Start Date
December 8 2016
End Date
October 31 2021
Last Update
March 20 2024
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G2M9