Clinical trial NCT06811532: Assessing Perfusion of Osteotomized Scapula and Lat Flap
Official title: Assessing Perfusion of an Osteotomised Scapula and Latissimus Dorsi Chimeric Free Flap on the Thoracodorsal Artery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Head and Neck Cancer
Keywords: head and neck cancer
scapular free flap
blood perfusion
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced head and neck cancer, benign tumors of the jaw and osteoradionecrosis, scheduled for head and neck reconstructive surgery using the scapular tip flap at London Health Sciences Centre (LHSC).

Brief summary: The gold standard for reconstruction of the jaw is the utilization of a bone free tissue transfer. Scapula reconstruction is an excellent option for elderly patients, those with significant comorbidities and for complex defects with large soft tissue reconstructive requirements. The scapula is supplied by the angular artery and circumflex scapula arteries. No studies have shown with objective measures, the viability of the lateral border of the scapula bone supplied by either the angular artery or circumflex scapula arteries. The aim of this observational study is to demonstrate with objective clinical measures, via SPY-Q software analysis, that the angular artery can adequately supply the scapula tip flap including with a single osteotomy giving two bone segments, in 30 patients who will undergo reconstructive head and neck surgery at LHSC.

Detailed description: The aim of this follow-up observational study is to demonstrate with objective clinical measures via SPY-Q software analysis, that the angular artery can adequately supply the scapula tip flap including a single distal osteotomy segment. 30 patients undergoing mandible or maxillary reconstruction with the scapular tip flap will be included. An osteotomy will be performed at up to 8cm from the scapular tip. The adequacy of blood supply to the scapula tip flap after a distal osteotomy and the latissimus dorsi muscle component of the flap will be measured intraoperatively, using SPY-Q software analysis.

Eligibility criteria: Inclusion Criteria:

* • Adult patients (18 years and older) seen at the head and neck clinic at London Health Sciences Centre (LHSC)

  * Planned to undergo a maxillary and/or mandibular reconstruction surgery with a scapular tip flap

Exclusion Criteria:

* • Younger than 18 years of age

  * History of failing microvascular flaps
  * Hypersensitivity toward ICG or related substances (e.g., imaging agents), defined as (based on ICG product monograph): possibly life-threatening dizziness, severe itching, hives, nausea, difficulty breathing, rash, low blood pressure)
  * Pregnant
  * Breastfeeding
  * Clinically apparent cognitive impairment

Primary outcomes:
measure: Adequacy of blood perfusion of osteomized lateral border of the scapula bone supplied by the angular artery
timeFrame: Intra-operatively
measure: Blood perfusion of osteomized lateral border of the scapula
timeFrame: Intra-operatively
Secondary outcomes:
measure: To assess flap viability
timeFrame: Intra-operatively; up to 10 days post-operatively
measure: Concordance between subjective and objective measure of blood perfusion
timeFrame: Intra-operatively; up to 10 days post-operatively
measure: Blood perfusion of latissmus dorsi
timeFrame: Intra-operatively
Other outcomes:
Locations:
Study officials:
affiliation: Department of Otolaryngology-Head & Neck Surgery, Western University Canada
name: Danielle MacNeil, MD
role: PRINCIPAL_INVESTIGATOR
References: