Imaging and modeling blood flow in perforator flaps for reconstructive surgery
Study and Modeling of Perforator Flap Vascularization
This trial tests PeriCam and PeriFlux imaging to map blood flow in skin and fat flaps used for reconstruction in adults with pelvic eschar or traumatic limb injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT07084740 on ClinicalTrials.gov |
What this trial studies
The project uses noninvasive perfusion imaging (PeriCam and PeriFlux) during reconstructive operations to record blood flow patterns across pedicled and free perforator flaps with surface area ≥50 cm2. Data from patients with pelvic eschar (pedicled flaps) and traumatic lower/upper limb injuries (free flaps) will be collected to build models of vascular territories (perforasomes) and perfusion behavior. Measurements are performed at the time of surgery at University Hospital Montpellier to generate perfusion maps and quantitative parameters. The goal is to improve understanding of flap vascularization beyond cadaveric studies by using live human perfusion data.
Who should consider this trial
Good fit: Adults aged 18–70 undergoing reconstructive surgery with a pedicled or free perforator flap of at least 50 cm2 for pelvic eschar or traumatic limb pathology, who can give consent and have social security coverage, are ideal candidates.
Not a fit: People outside the 18–70 age range, those receiving smaller flaps (<50 cm2) or different reconstruction techniques, and those who cannot consent or lack required social coverage are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the work could help surgeons better predict which parts of a flap will stay healthy and reduce flap failure or unnecessary muscle harvest.
How similar studies have performed: Previous clinical and experimental work using perfusion imaging and the perforasome concept has shown promise for predicting flap viability, so this project builds on existing approaches rather than introducing an entirely untested idea.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 70 * Reconstructive surgery using pedicled perforating flap or free perforating flap. * Flap with a surface area of at least 50 cm2 (in order to have a sufficiently large surface area for good perfusion visualization) * Pedicled perforating flaps group: Patients with pelvic eschar * Free perforating flaps group: Traumatic pathology of the lower and/or upper limb Exclusion Criteria: * No consent obtained * No social security affiliation * Persons under court protection * Persons participating in another study with an exclusion period still in progress
Where this trial is running
Montpellier
- University Hospital Montpellier — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Christian HERLIN, MD, PhD — University Hospital, Montpellier
- Study coordinator: Christian HERLIN, MD, PhD
- Email: c-herlin@chu-montpellier.fr
- Phone: +33467330589
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.