Assessing Perfusion of Osteotomized Scapula and Lat Flap

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: Blood perfusion analysis using SPY-Q software

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Agnieszka Dzioba, PhD; Phone Number: 519-685-8500; Email: Agnieszka.Dzioba@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Intra-operatively
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	Intra-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess flap viability	To evaluate whether scapular tip flaps with an osteotomy with adequate bone perfusion scores resulted in surgical success (flap viability)	Intra-operatively; up to 10 days post-operatively
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	Intra-operatively; up to 10 days post-operatively
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	Intra-operatively

Collaborators and Investigators

• Sponsor: Western University, Canada
• Investigators: Principal Investigator: Danielle MacNeil, MD, Department of Otolaryngology-Head & Neck Surgery, Western University Canada

Study record dates

Study Major Dates

• Study Start (Estimated): May 7, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: head and neck cancer; blood perfusion; scapular free flap
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 126223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be made available upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No