Study and Modeling of Perforator Flap Vascularization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PeriCam and PeriFlux measurements.
- Who it may be relevant to
- Registry conditions: Reconstructive Surgery Using Pedicled Perforating or Free Perforating Flaps, Pelvic Eschar, Traumatic Pathology of the Lower and/or Upper Limb. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The aim of reconstructive surgery is to restore physical integrity altered by trauma, congenital malformations or cancerous pathologies. Several techniques are available, including flap surgery, which enables tissue to be moved from one anatomical location to another. Perforating skin/subcutaneous flaps are segments of skin and subcutaneous cellular tissue vascularized by a feeder vascular pedicle. This surgical technique has virtually zero donor-site morbidity, as it is no longer necessary to harvest muscle to ensure reliable vascularization of the flap. Flap vascularization is a variable mechanism, complex to describe and understand. For cutaneous and subcutaneous (fatty) flaps, which account for the majority of flaps used, perforator flaps (vascularized by a subcutaneous perforator artery) have become the benchmark. Unfortunately, their vascularization is currently poorly understood, and depends on experimental work carried out on fresh cadaveric anatomical specimens. These cadaveric studies fail to take into account several key factors influencing perforasomes (perforasome: skin territory vascularized by a pedicle), namely body temperature, blood pressure, heart rate, intraoperative patient position and biological parameters.
Interventions
- Diagnostic test PeriCam and PeriFlux measurements
PeriCam and PeriFlux measurements
Primary outcome measures
- study the superficial tissue perfusion of flaps (flow speed) [Time frame: Between Day -1 and Day +1 of surgery]
- study the superficial tissue perfusion of flaps (flow speed) [Time frame: Between Day -1 and Day +1 of surgery]
- study the superficial tissue perfusion of flaps (Infusion quality) [Time frame: Between Day -1 and Day +1 of surgery]
- study the superficial tissue perfusion of flaps (Infusion quality) [Time frame: Between Day -1 and Day +1 of surgery]
- study the superficial tissue perfusion of flaps (Oxygenation quality) [Time frame: Between Day -1 and Day +1 of surgery]
- study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale) [Time frame: Between Day -1 and Day +1 of surgery]
Secondary outcome measures (12)
- study the superficial tissue perfusion of flaps (flow speed) [Time frame: Between Day -1 and Day +3 of surgery]
- study the superficial tissue perfusion of flaps (flow speed) [Time frame: Between Day -1 and Day +3 of surgery]
- study the superficial tissue perfusion of flaps (flow speed) [Time frame: Between Day -1 and Day +30 of surgery]
- study the superficial tissue perfusion of flaps (flow speed) [Time frame: Between Day -1 and Day +30 of surgery]
- study the superficial tissue perfusion of flaps (Infusion quality) [Time frame: Between Day -1 and Day +3 of surgery]
- study the superficial tissue perfusion of flaps (Infusion quality) [Time frame: Between Day -1 and Day +3 of surgery]
- study the superficial tissue perfusion of flaps (Infusion quality) [Time frame: Between Day -1 and Day +30 of surgery]
- study the superficial tissue perfusion of flaps (Infusion quality) [Time frame: Between Day -1 and Day +30 of surgery]
- study the superficial tissue perfusion of flaps (Oxygenation quality) [Time frame: Between Day -1 and Day +3 of surgery]
- study the superficial tissue perfusion of flaps (Oxygenation quality) [Time frame: Between Day -1 and Day +30 of surgery]
- study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale) [Time frame: Between Day -1 and Day +3 of surgery]
- study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale) [Time frame: Between Day -1 and Day +30 of surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- University Hospital Montpellier — Montpellier
Identifiers
NCT: NCT07084740 · RECHMPL25_0082 · 2025-A00951-48