Study and Modeling of Perforator Flap Vascularization

Not Applicable

Not yet recruiting

• Conditions: Reconstructive Surgery Using Pedicled Perforating or Free Perforating Flaps; Pelvic Eschar; Traumatic Pathology of the Lower and/or Upper Limb

• Registration Number: NCT07084740
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-02
• Study Start: 2025-07-15
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-24
• Last Update Posted: 2025-07-24
• Primary Completion: 2026-07-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
study the superficial tissue perfusion of flaps (Infusion quality)	Between Day -1 and Day +1 of surgery	with PeriFlux 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 (flow speed)	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 Outcome Measures

Name	Time	Method
study the superficial tissue perfusion of flaps (flow speed)	Between Day -1 and Day +30 of surgery	with PeriFlux device
study the superficial tissue perfusion of flaps (Infusion quality)	Between Day -1 and Day +30 of surgery	with PeriFlux device
study the superficial tissue perfusion of flaps (Oxygenation quality)	Between Day -1 and Day +30 of surgery	with PeriFlux device
study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale)	Between Day -1 and Day +30 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).