Pelvic Eschar, Reconstructive Surgery Using Pedicled Perforating or Free Perforating Flaps, Traumatic Pathology of the Lower and/or Upper Limb
Conditions
Keywords
Perforasome, perforator flap, PeriCam, Periflux EPOS, tissue perfusion
Brief summary
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_TESTPeriCam and PeriFlux measurements
PeriCam and PeriFlux measurements
Sponsors
University Hospital, Montpellier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| study the superficial tissue perfusion of flaps (flow speed) | Between Day -1 and Day +1 of surgery | with PeriCam device |
| study the superficial tissue perfusion of flaps (Infusion quality) | Between Day -1 and Day +1 of surgery | with PeriCam device |
| study the superficial tissue perfusion of flaps (Oxygenation quality) | Between Day -1 and Day +1 of surgery | with PeriFlux device |
| study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale) | Between Day -1 and Day +1 of surgery | with PeriCam device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| study the superficial tissue perfusion of flaps (flow speed) | Between Day -1 and Day +3 of surgery | with PeriCam device |
| study the superficial tissue perfusion of flaps (Infusion quality) | Between Day -1 and Day +3 of surgery | with PeriCam device |
| study the superficial tissue perfusion of flaps (Oxygenation quality) | Between Day -1 and Day +3 of surgery | with PeriFlux device |
| study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale) | Between Day -1 and Day +3 of surgery | with PeriCam device |
| Study the superficial tissue perfusion of flaps in relation to ultrasound exploration (flap perforating vessel flow) | Between Day -1 and Day +1 of surgery | — |
| Study the superficial tissue perfusion of flaps in relation to clinical observations (skin recoloration time) | Between Day -1 and Day +1 of surgery | — |
| Number of participants with signs of tissue suffering (delayed capillary refill, color change, skin breakdown, blister) as observed on clinical examination | Between Day -1 and Day +1 of surgery | Clinical signs of tissue suffering will be recorded based on predefined clinical criteria: capillary refill time \> 3 seconds, local discoloration (pallor or cyanosis), or cutaneous ulceration or blisters. These signs will be assessed by a trained plastic surgeon and documented on standardized observation forms. |
| Study the superficial tissue perfusion of flaps in relation to clinical observations ( scarring). | Between Day -1 and Day +1 of surgery | Scarification will be performed on the flap surface in the area suspected of tissue compromise, using a sterile needle to superficially scratch the skin. The assessment will document whether bleeding occurs at the site of scarification. If bleeding is present, it will be classified as: arterial bleeding (bright red), venous bleeding (dark red), no bleeding (indicative of dry necrosis or severe ischemia). |
Countries
France
Contacts
CONTACTChristian HERLIN, MD, PhD
PRINCIPAL_INVESTIGATORChristian HERLIN, MD, PhD
University Hospital, Montpellier
Outcome results
None listed