University Hospital Montpellier
Montpellier, 34000, France
Location status: Recruiting
NCT Number: NCT07084740
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Montpellier, 34000, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PeriCam and PeriFlux measurements
Time frame: Between Day -1 and Day +1 of surgery
with PeriCam device
Time frame: Between Day -1 and Day +1 of surgery
with PeriFlux device
Time frame: Between Day -1 and Day +1 of surgery
with PeriCam device
Time frame: Between Day -1 and Day +1 of surgery
with PeriFlux device
Time frame: Between Day -1 and Day +1 of surgery
with PeriFlux device
Time frame: Between Day -1 and Day +1 of surgery
with PeriCam device
Time frame: Between Day -1 and Day +3 of surgery
with PeriCam device
Time frame: Between Day -1 and Day +3 of surgery
with PeriFlux device
Time frame: Between Day -1 and Day +30 of surgery
with PeriCam device
Time frame: Between Day -1 and Day +30 of surgery
with PeriFlux device
Time frame: Between Day -1 and Day +3 of surgery
with PeriCam device
Time frame: Between Day -1 and Day +3 of surgery
with PeriFlux device
Time frame: Between Day -1 and Day +30 of surgery
with PeriCam device
Time frame: Between Day -1 and Day +30 of surgery
with PeriFlux device
Time frame: Between Day -1 and Day +3 of surgery
with PeriFlux device
Time frame: Between Day -1 and Day +30 of surgery
with PeriFlux device
Time frame: Between Day -1 and Day +3 of surgery
with PeriCam device
Time frame: Between Day -1 and Day +30 of surgery
with PeriCam device
Time frame: Between Day -1 and Day +1 of surgery
Time frame: Between Day -1 and Day +1 of surgery
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.
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).
Contact information is provided by the study sponsor or research team.
University Hospital, Montpellier
Other
Acronym: EMoVaLP
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.