AI tool to locate skin perforators for fibula free flap reconstruction
Validation of An Artificial Intelligence-Enabled Skin Perforator Segmentation Tool in Computer-Assisted Osteocutaneous Fibular Free Flap Harvest: A Clinical Trial
This project will try an AI tool to automatically find the small skin blood vessels surgeons use when adults have fibula osteocutaneous free flap reconstruction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 49 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06634472 on ClinicalTrials.gov |
What this trial studies
This single-arm, single-center observational study tests an AI-enabled vessel segmentation tool to predict skin perforator locations from preoperative CT angiography in patients undergoing fibula osteocutaneous free flap reconstruction. The AI segments vessels on CTA and outputs targeted perforator sites that are compared to intraoperative findings to count true/false positives and negatives. The primary endpoint is predictive accuracy, with secondary outcomes including sensitivity, specificity, positive predictive value, and negative predictive value. Demographics and perioperative data are collected on case report forms to support analysis of factors affecting performance.
Who should consider this trial
Good fit: Adults (≥18) who consent and are scheduled for immediate or secondary osteocutaneous fibula free flap reconstruction and can undergo preoperative CT angiography are ideal candidates.
Not a fit: Patients who are pregnant, medically unfit for surgery, allergic to iodinated contrast, or who have anatomical variations that prevent safe fibula harvest are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If accurate, the tool could improve preoperative planning and make fibula flap harvests safer, faster, and more predictable.
How similar studies have performed: Handheld Doppler and CTA have been used previously with variable concordance to actual perforator locations, and AI-based segmentation for this specific purpose is relatively novel with limited prior validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years, both genders; 2. Provided signed and dated informed consent form; 3. Indicated for immediate or secondary reconstructive surgery with osteocutaneous fibula free flap. Exclusion Criteria: 1. Patients who are pregnant; 2. Patients who have medically compromised conditions and cannot tolerate surgery; 3. Patients who are unable to receive pre-operative computed tomography angiogram scans, such as those with iodine allergy; 4. Patients who have anatomical variation preventing the safe harvest of fibula free flap.
Where this trial is running
Hong Kong
- The University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Jane J Pu, MDS — The University of Hong Kong
- Study coordinator: Jane J PU, MDS
- Email: drjanepu@hku.hk
- Phone: 852-28590534
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.