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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00951-48 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PeriCam and PeriFlux measurements | Experimental | PeriCam and PeriFlux measurements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PeriCam and PeriFlux measurements | Diagnostic Test | PeriCam and PeriFlux measurements |
|
| Measure | Description | Time Frame |
|---|---|---|
| study the superficial tissue perfusion of flaps (flow speed) | with PeriCam device | Between Day -1 and Day +1 of surgery |
| study the superficial tissue perfusion of flaps (flow speed) | with PeriFlux device | Between Day -1 and Day +1 of surgery |
| study the superficial tissue perfusion of flaps (Infusion quality) | with PeriCam device | Between Day -1 and Day +1 of surgery |
| study the superficial tissue perfusion of flaps (Infusion quality) | with PeriFlux device | Between Day -1 and Day +1 of surgery |
| study the superficial tissue perfusion of flaps (Oxygenation quality) | with PeriFlux device | Between Day -1 and Day +1 of surgery |
| study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale) | with PeriCam device | Between Day -1 and Day +1 of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| study the superficial tissue perfusion of flaps (flow speed) | with PeriCam device | Between Day -1 and Day +3 of surgery |
| study the superficial tissue perfusion of flaps (flow speed) | with PeriFlux device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian HERLIN, MD, PhD | Contact | +33467330589 | c-herlin@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christian HERLIN, MD, PhD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Montpellier | Recruiting | Montpellier | 34000 | France |
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| Between Day -1 and Day +3 of surgery |
| study the superficial tissue perfusion of flaps (flow speed) | with PeriCam device | Between Day -1 and Day +30 of surgery |
| study the superficial tissue perfusion of flaps (flow speed) | with PeriFlux device | Between Day -1 and Day +30 of surgery |
| study the superficial tissue perfusion of flaps (Infusion quality) | with PeriCam device | Between Day -1 and Day +3 of surgery |
| study the superficial tissue perfusion of flaps (Infusion quality) | with PeriFlux device | Between Day -1 and Day +3 of surgery |
| study the superficial tissue perfusion of flaps (Infusion quality) | with PeriCam device | Between Day -1 and Day +30 of surgery |
| study the superficial tissue perfusion of flaps (Infusion quality) | with PeriFlux device | Between Day -1 and Day +30 of surgery |
| study the superficial tissue perfusion of flaps (Oxygenation quality) | with PeriFlux device | Between Day -1 and Day +3 of surgery |
| study the superficial tissue perfusion of flaps (Oxygenation quality) | with PeriFlux device | Between Day -1 and Day +30 of surgery |
| study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale) | with PeriCam device | Between Day -1 and Day +3 of surgery |
| study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale) | with PeriCam device | Between Day -1 and Day +30 of surgery |
| 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 | 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. | Between Day -1 and Day +1 of surgery |
| Study the superficial tissue perfusion of flaps in relation to clinical observations ( scarring). | 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). | Between Day -1 and Day +1 of surgery |