Assessing Perfusion of Osteotomized Scapula and Lat Flap

NCT06811532 | Not Yet Recruiting

• 1 other identifier: 126223
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; scapular free flap; blood perfusion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• To assess flap viability

  Intra-operatively; up to 10 days post-operatively

• Concordance between subjective and objective measure of blood perfusion

  Intra-operatively; up to 10 days post-operatively

• Blood perfusion of latissmus dorsi

  Intra-operatively

Interventions

Blood perfusion analysis using SPY-Q software OTHER

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Danielle MacNeil, MD

  Department of Otolaryngology-Head & Neck Surgery, Western University Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnieszka Dzioba, PhD

CONTACT

519-685-8500; Agnieszka.Dzioba@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: May 7, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share