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NCT Number: NCT07084740

Study and Modeling of Perforator Flap Vascularization

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Montpellier

Montpellier, 34000, France

Location status: Recruiting

Location contact

Christian MD Herlin

CONTACT

[email protected]

06.19.71.55.57

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PeriCam and PeriFlux measurements

Diagnostic Test

PeriCam and PeriFlux measurements

Primary outcomes

  1. study the superficial tissue perfusion of flaps (flow speed)

    Time frame: Between Day -1 and Day +1 of surgery

    with PeriCam device

  2. study the superficial tissue perfusion of flaps (flow speed)

    Time frame: Between Day -1 and Day +1 of surgery

    with PeriFlux device

  3. study the superficial tissue perfusion of flaps (Infusion quality)

    Time frame: Between Day -1 and Day +1 of surgery

    with PeriCam device

  4. study the superficial tissue perfusion of flaps (Infusion quality)

    Time frame: Between Day -1 and Day +1 of surgery

    with PeriFlux device

  5. study the superficial tissue perfusion of flaps (Oxygenation quality)

    Time frame: Between Day -1 and Day +1 of surgery

    with PeriFlux device

  6. study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale)

    Time frame: Between Day -1 and Day +1 of surgery

    with PeriCam device

Secondary outcomes

  1. study the superficial tissue perfusion of flaps (flow speed)

    Time frame: Between Day -1 and Day +3 of surgery

    with PeriCam device

  2. study the superficial tissue perfusion of flaps (flow speed)

    Time frame: Between Day -1 and Day +3 of surgery

    with PeriFlux device

  3. study the superficial tissue perfusion of flaps (flow speed)

    Time frame: Between Day -1 and Day +30 of surgery

    with PeriCam device

  4. study the superficial tissue perfusion of flaps (flow speed)

    Time frame: Between Day -1 and Day +30 of surgery

    with PeriFlux device

  5. study the superficial tissue perfusion of flaps (Infusion quality)

    Time frame: Between Day -1 and Day +3 of surgery

    with PeriCam device

  6. study the superficial tissue perfusion of flaps (Infusion quality)

    Time frame: Between Day -1 and Day +3 of surgery

    with PeriFlux device

  7. study the superficial tissue perfusion of flaps (Infusion quality)

    Time frame: Between Day -1 and Day +30 of surgery

    with PeriCam device

  8. study the superficial tissue perfusion of flaps (Infusion quality)

    Time frame: Between Day -1 and Day +30 of surgery

    with PeriFlux device

  9. study the superficial tissue perfusion of flaps (Oxygenation quality)

    Time frame: Between Day -1 and Day +3 of surgery

    with PeriFlux device

  10. study the superficial tissue perfusion of flaps (Oxygenation quality)

    Time frame: Between Day -1 and Day +30 of surgery

    with PeriFlux device

  11. study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale)

    Time frame: Between Day -1 and Day +3 of surgery

    with PeriCam device

  12. study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale)

    Time frame: Between Day -1 and Day +30 of surgery

    with PeriCam device

  13. Study the superficial tissue perfusion of flaps in relation to ultrasound exploration (flap perforating vessel flow)

    Time frame: Between Day -1 and Day +1 of surgery

  14. Study the superficial tissue perfusion of flaps in relation to clinical observations (skin recoloration time)

    Time frame: Between Day -1 and Day +1 of surgery

  15. Number of participants with signs of tissue suffering (delayed capillary refill, color change, skin breakdown, blister) as observed on clinical examination

    Time frame: 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.

  16. Study the superficial tissue perfusion of flaps in relation to clinical observations ( scarring).

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Christian HERLIN, MD, PhD

CONTACT

[email protected]

+33467330589

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: EMoVaLP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.