Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-01 @ 2:41 AM
Study NCT ID:
NCT06811532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Perfusion of Osteotomized Scapula and Lat Flap
Sponsor:
Western University, Canada
Organization:
Study Overview
Official Title:
Assessing Perfusion of an Osteotomised Scapula and Latissimus Dorsi Chimeric Free Flap on the Thoracodorsal Artery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: