Assessing Perfusion of Osteotomized Scapula and Lat Flap

NCT ID: NCT06811532

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-07
• Study Completion Date: 2027-03-30

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.

Conditions

Head and Neck Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Danielle MacNeil

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danielle MacNeil, MD

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

Agnieszka Dzioba, PhD

Role: CONTACT

Agnieszka.Dzioba@lhsc.on.ca

519-685-8500

Other Identifiers

126223

Identifier Type: -

Identifier Source: org_study_id