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Study and Modeling of Perforator Flap Vascularization (EMoVaLP)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Not yet enrolling

Conditions

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

Treatments

Diagnostic Test: PeriCam and PeriFlux measurements

Study type

Interventional

Funder types

Other

Identifiers

NCT07084740
RECHMPL25_0082
2025-A00951-48 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

PeriCam and PeriFlux measurements
Experimental group
Description:
PeriCam and PeriFlux measurements
Treatment:
Diagnostic Test: PeriCam and PeriFlux measurements

Trial contacts and locations

0

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Central trial contact

Christian HERLIN, MD, PhD

Data sourced from clinicaltrials.gov

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