Study and Modeling of Perforator Flap Vascularization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2026-07-15

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PeriCam and PeriFlux measurements

Group Type EXPERIMENTAL

PeriCam and PeriFlux measurements

Intervention Type DIAGNOSTIC_TEST

PeriCam and PeriFlux measurements

Interventions

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PeriCam and PeriFlux measurements

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No