Assessing Perfusion of Osteotomized Scapula and Lat Flap
ConditionHead and Neck Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWestern University, Canada
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
• 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
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood perfusion analysis using SPY-Q software
Other interventionUse of the SPY-Q analysis software during surgery to calculate bone profusion scores on several areas of the scapular tip flap (endosteum of scapula bone segments and latissimus dorsi muscle component).
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Adequacy of blood perfusion of osteomized lateral border of the scapula bone supplied by the angular artery
To measure the adequacy of blood perfusion of osteotomised lateral border of the scapula bone supplied by the angular artery via SPY-Q analysis in patients undergoing a scapular tip flap for reconstruction of a jaw defect
Time frame
Intra-operatively2
Blood perfusion of osteomized lateral border of the scapula
To measure the adequacy of blood perfusion of osteotomised lateral border of the scapula bone supplied by the angular artery via SPY-Q analysis in patients undergoing a scapular tip flap for reconstruction of a jaw defect
Time frame
Intra-operativelySecondary outcomes
1
To assess flap viability
To evaluate whether scapular tip flaps with an osteotomy with adequate bone perfusion scores resulted in surgical success (flap viability)
Time frame
Intra-operatively; up to 10 days post-operatively2
Concordance between subjective and objective measure of blood perfusion
To assess the concordance between visual inspection of blood perfusion and SPY-Q analysis of blood perfusion
Time frame
Intra-operatively; up to 10 days post-operatively3
Blood perfusion of latissmus dorsi
To measure the adequacy of blood perfusion of the latissimus dorsi muscle component of the scapula flap via SPY-Q analysis
Time frame
Intra-operativelyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: