This prospective ex vivo study will evaluate thermal damage produced during electrocautery cutting of explanted tissue from patients undergoing clinically indicated surgical removal of gluteal biopolymers. The study will focus on three tissue types: fat flap tissue, fibrotic tissue, and muscular tissue.
The clinical surgical procedure will not be modified by study participation. All experimental thermal measurements will be performed on tissue that has already been removed from the patient as part of standard surgical care.
In fat tissue, standardized blocks measuring 1.25 cm × 1 cm × 1 cm will be prepared from the explanted specimen. Thermal measurements will be performed for each combination of electrocautery tip, power setting, and electrosurgical mode. The evaluated tips will be a blunt electrocautery tip and a Utah electrocautery tip. The evaluated power settings will be 25 watts and 50 watts. The evaluated modes will be cut Blend 2 and coagulation. For each combination, three thermal measurements will be obtained.
In fibrotic and muscular tissue, due to limited tissue availability, the evaluation will be restricted to 25 watts using the blunt and Utah tips in cut Blend 2 and coagulation modes. Thermal measurements will be obtained from electrocautery cuts performed during removal of the clinically indicated specimen.
Thermal measurements will be recorded using a FLIR C3-X thermal camera. The camera settings will include emissivity of 0.95, reflected temperature of 20°C, operating room humidity of 57%, operating room temperature of 22°C, and a fixed measurement distance of 50 cm.
Histopathological evaluation will be performed on one representative sample per experimental combination. The pathology assessor will be blinded to the electrocautery tip, power setting, and mode used for each coded sample. The primary outcome will be maximum histological depth of thermal damage.
Patients with clinical and/or imaging diagnosis of gluteal soft tissue infiltration by biopolymers or alloplastic filler material.
Patients scheduled for clinically indicated surgical removal of gluteal biopolymer-infiltrated tissue.
Ability to understand the study and provide written informed consent.
Availability of explanted tissue suitable for ex vivo thermal and histopathological assessment.
Refusal or inability to provide informed consent.
Intraoperative finding that explanted tissue is insufficient for ex vivo thermal assessment.
Active severe infection requiring urgent deviation from the planned surgical protocol.
Extensive tissue necrosis or contamination preventing standardized ex vivo thermal assessment.
The study population will be drawn from patients treated at Clínica Bioderma in Medellín, Colombia, who are scheduled to undergo clinically indicated surgical removal of gluteal tissue affected by prior biopolymer injection. Participants will represent the clinical population managed by the principal investigator for surgical treatment of gluteal biopolymer infiltration. The ex vivo thermal and histopathological assessments will be performed only on tissue already removed during the planned surgical procedure.
Other
Prospective
Not listed
Maximum Histological Depth of Thermal Damage
Maximum depth of thermal tissue damage measured from the electrocautery cut margin to viable tissue on histopathological examination. The measurement will be recorded in micrometers or millimeters. Thermal damage may include coagulative necrosis, carbonization, collagen retraction, architectural distortion, vascular wall injury, and loss of tissue architecture.
Maximum Temperature During Electrocautery Cutting
Highest temperature recorded during each ex vivo electrocautery cut using the FLIR C3-X thermal camera.
Temperature 10 Seconds After Electrocautery Cutting
Tissue temperature recorded 10 seconds after completion of each ex vivo electrocautery cut.
Temperature 30 Seconds After Electrocautery Cutting
Tissue temperature recorded 30 seconds after completion of each ex vivo electrocautery cut.
Histological Carbonization Score
Degree of carbonization at the electrocautery cut margin, classified as absent, mild, moderate, or severe by histopathological assessment.
Baseline Tissue Temperature
Temperature of the tissue sample immediately before electrocautery activation, measured using the FLIR C3-X thermal camera.
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