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Not yet recruiting NCT06811532

Assessing Perfusion of Osteotomized Scapula and Lat Flap

— Observational Head and Neck Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood perfusion analysis using SPY-Q software.
Who it may be relevant to
Registry conditions: Head and Neck Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Other Blood 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).

Primary outcome measures

  • Adequacy of blood perfusion of osteomized lateral border of the scapula bone supplied by the angular artery [Time frame: Intra-operatively]
  • Blood perfusion of osteomized lateral border of the scapula [Time frame: Intra-operatively]
Secondary outcome measures (3)
  • To assess flap viability [Time frame: Intra-operatively; up to 10 days post-operatively]
  • Concordance between subjective and objective measure of blood perfusion [Time frame: Intra-operatively; up to 10 days post-operatively]
  • Blood perfusion of latissmus dorsi [Time frame: Intra-operatively]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06811532 · 126223

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗