Reconstructive Surgery Using Pedicled Perforating or Free Perforating FlapsEMoVaLPNCT07084740
Study and Modeling of Perforator Flap Vascularization
A study testing PeriCam and PeriFlux measurements in people with Reconstructive Surgery Using Pedicled Perforating or Free Perforating Flaps and Pelvic Eschar, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Reconstructive Surgery Using Pedicled Perforating or Free Perforating Flaps, Pelvic Eschar, Traumatic Pathology of the Lower and/or Upper Limb
- What is being tested?
- PeriCam and PeriFlux measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No consent obtained
- No social security affiliation
- Persons under court protection
- Persons participating in another study with an exclusion period still in progress
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital Montpellier
Montpellier, 34000
Christian MD Herlin, 06.19.71.55.57, c-herlin@chu-montpellier.fr
About this study
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.
- Conditions
- Reconstructive Surgery Using Pedicled Perforating or Free Perforating Flaps, Pelvic Eschar, Traumatic Pathology of the Lower and/or Upper Limb
- Being tested
- PeriCam and PeriFlux measurements
- Keywords
- Perforasome, perforator flap, PeriCam, Periflux EPOS, tissue perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeriCam and PeriFlux measurementsDiagnostic test
PeriCam and PeriFlux measurements
| Study group | Role | What they receive |
|---|---|---|
| PeriCam and PeriFlux measurements | Experimental | PeriCam and PeriFlux measurements Receives: Diagnostic Test: PeriCam and PeriFlux measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
study the superficial tissue perfusion of flaps (flow speed)
with PeriCam device
Measured: Between Day -1 and Day +1 of surgery
study the superficial tissue perfusion of flaps (flow speed)
with PeriFlux device
Measured: Between Day -1 and Day +1 of surgery
study the superficial tissue perfusion of flaps (Infusion quality)
with PeriCam device
Measured: Between Day -1 and Day +1 of surgery
study the superficial tissue perfusion of flaps (Infusion quality)
with PeriFlux device
Measured: Between Day -1 and Day +1 of surgery
study the superficial tissue perfusion of flaps (Oxygenation quality)
with PeriFlux device
Measured: Between Day -1 and Day +1 of surgery
study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale)
with PeriCam device
Measured: Between Day -1 and Day +1 of surgery
Secondary outcomes (16)
study the superficial tissue perfusion of flaps (flow speed)
with PeriCam device
Measured: Between Day -1 and Day +3 of surgery
study the superficial tissue perfusion of flaps (flow speed)
with PeriFlux device
Measured: Between Day -1 and Day +3 of surgery
study the superficial tissue perfusion of flaps (flow speed)
with PeriCam device
Measured: Between Day -1 and Day +30 of surgery
study the superficial tissue perfusion of flaps (flow speed)
with PeriFlux device
Measured: Between Day -1 and Day +30 of surgery
study the superficial tissue perfusion of flaps (Infusion quality)
with PeriCam device
Measured: Between Day -1 and Day +3 of surgery
study the superficial tissue perfusion of flaps (Infusion quality)
with PeriFlux device
Measured: Between Day -1 and Day +3 of surgery
study the superficial tissue perfusion of flaps (Infusion quality)
with PeriCam device
Measured: Between Day -1 and Day +30 of surgery
study the superficial tissue perfusion of flaps (Infusion quality)
with PeriFlux device
Measured: Between Day -1 and Day +30 of surgery
study the superficial tissue perfusion of flaps (Oxygenation quality)
with PeriFlux device
Measured: Between Day -1 and Day +3 of surgery
study the superficial tissue perfusion of flaps (Oxygenation quality)
with PeriFlux device
Measured: Between Day -1 and Day +30 of surgery
study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale)
with PeriCam device
Measured: Between Day -1 and Day +3 of surgery
study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale)
with PeriCam device
Measured: Between Day -1 and Day +30 of surgery
Study the superficial tissue perfusion of flaps in relation to ultrasound exploration (flap perforating vessel flow)
Measured: Between Day -1 and Day +1 of surgery
Study the superficial tissue perfusion of flaps in relation to clinical observations (skin recoloration time)
Measured: 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.
Measured: 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).
Measured: Between Day -1 and Day +1 of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start15 Feb 2026
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructive Surgery Using Pedicled Perforating or Free Perforating FlapsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian HERLIN, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084740
- Sponsor's protocol ID
- RECHMPL25_0082
- Other IDs
- 2025-A00951-48
- Acronym
- EMoVaLP
- Status last verified
- Apr 2026
- First submitted
- 2 Jul 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study and Modeling of Perforator Flap Vascularization
- ClinicalTrials.gov ID
- NCT07084740
- Acronym / sponsor ID
- EMoVaLP / RECHMPL25_0082
- Conditions
- Reconstructive Surgery Using Pedicled Perforating or Free Perforating Flaps, Pelvic Eschar, Traumatic Pathology of the Lower and/or Upper Limb
- Keywords
- Perforasome, perforator flap, PeriCam, Periflux EPOS, tissue perfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PeriCam and PeriFlux measurements | Experimental | Diagnostic Test: PeriCam and PeriFlux measurementsPeriCam and PeriFlux measurements |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- No consent obtained
- No social security affiliation
- Persons under court protection
- Persons participating in another study with an exclusion period still in progress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PeriCam and PeriFlux measurementsPeriCam and PeriFlux measurements | Diagnostic test | PeriCam and PeriFlux measurements |
Primary outcome
study the superficial tissue perfusion of flaps (flow speed)
Time frame: Between Day -1 and Day +1 of surgery
with PeriCam device
study the superficial tissue perfusion of flaps (flow speed)
Time frame: Between Day -1 and Day +1 of surgery
with PeriFlux device
study the superficial tissue perfusion of flaps (Infusion quality)
Time frame: Between Day -1 and Day +1 of surgery
with PeriCam device
study the superficial tissue perfusion of flaps (Infusion quality)
Time frame: Between Day -1 and Day +1 of surgery
with PeriFlux device
study the superficial tissue perfusion of flaps (Oxygenation quality)
Time frame: Between Day -1 and Day +1 of surgery
with PeriFlux device
study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale)
Time frame: Between Day -1 and Day +1 of surgery
with PeriCam device
16 secondary outcomes
study the superficial tissue perfusion of flaps (flow speed)
Time frame: Between Day -1 and Day +3 of surgery
study the superficial tissue perfusion of flaps (flow speed)
Time frame: Between Day -1 and Day +3 of surgery
study the superficial tissue perfusion of flaps (flow speed)
Time frame: Between Day -1 and Day +30 of surgery
study the superficial tissue perfusion of flaps (flow speed)
Time frame: Between Day -1 and Day +30 of surgery
study the superficial tissue perfusion of flaps (Infusion quality)
Time frame: Between Day -1 and Day +3 of surgery
study the superficial tissue perfusion of flaps (Infusion quality)
Time frame: Between Day -1 and Day +3 of surgery
study the superficial tissue perfusion of flaps (Infusion quality)
Time frame: Between Day -1 and Day +30 of surgery
study the superficial tissue perfusion of flaps (Infusion quality)
Time frame: Between Day -1 and Day +30 of surgery
study the superficial tissue perfusion of flaps (Oxygenation quality)
Time frame: Between Day -1 and Day +3 of surgery
study the superficial tissue perfusion of flaps (Oxygenation quality)
Time frame: Between Day -1 and Day +30 of surgery
study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale)
Time frame: Between Day -1 and Day +3 of surgery
study the superficial tissue perfusion of flaps (Colorimetric infusion quality scale)
Time frame: Between Day -1 and Day +30 of surgery
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
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
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
Study the superficial tissue perfusion of flaps in relation to clinical observations ( scarring).
Time frame: Between Day -1 and Day +1 of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian HERLIN, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PeriCam and PeriFlux measurements in people with Reconstructive Surgery Using Pedicled Perforating or Free Perforating Flaps and Pelvic Eschar, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian HERLIN, MD, PhD (+33467330589, c-herlin@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
study the superficial tissue perfusion of flaps (flow speed) (time frame: Between Day -1 and Day +1 of surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.