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Assessing Perfusion of Osteotomized Scapula and Lat Flap

Assessing Perfusion of an Osteotomised Scapula and Latissimus Dorsi Chimeric Free Flap on the Thoracodorsal Artery

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06811532
Enrollment
30
Registered
2025-02-06
Start date
2025-05-07
Completion date
2027-03-30
Last updated
2025-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

head and neck cancer, scapular free flap, blood perfusion

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.

Interventions

OTHERBlood perfusion analysis using SPY-Q software

Use 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).

Sponsors

Western University, Canada
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adequacy of blood perfusion of osteomized lateral border of the scapula bone supplied by the angular arteryIntra-operativelyTo 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
Blood perfusion of osteomized lateral border of the scapulaIntra-operativelyTo 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

Secondary

MeasureTime frameDescription
To assess flap viabilityIntra-operatively; up to 10 days post-operativelyTo evaluate whether scapular tip flaps with an osteotomy with adequate bone perfusion scores resulted in surgical success (flap viability)
Concordance between subjective and objective measure of blood perfusionIntra-operatively; up to 10 days post-operativelyTo assess the concordance between visual inspection of blood perfusion and SPY-Q analysis of blood perfusion
Blood perfusion of latissmus dorsiIntra-operativelyTo measure the adequacy of blood perfusion of the latissimus dorsi muscle component of the scapula flap via SPY-Q analysis

Contacts

Primary ContactAgnieszka Dzioba, PhD
Agnieszka.Dzioba@lhsc.on.ca519-685-8500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026