An observational study in Thermal Injury Response, Soft Tissue Disease and Granuloma, Foreign-Body, sponsored by Research Inc. Not yet recruiting at 1 site in Colombia. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Research Inc · Observational
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.
Injection of biopolymers or alloplastic filler materials into soft tissues may result in chronic inflammation, fibrosis, foreign body reaction, granuloma formation, migration, pain, deformity, and functional impairment. In selected patients, surgical removal of affected tissue is clinically indicated.
Electrocautery is commonly used during surgical dissection and tissue handling. However, the thermal behavior of biopolymer-infiltrated tissues and the relative thermal damage produced by different electrocautery tips, power settings, and electrosurgical modes have not been adequately characterized.
This study is designed as a prospective ex vivo evaluation of thermal damage in tissue already removed from patients undergoing clinically indicated surgical removal of gluteal biopolymers. The study does not alter the surgical indication, surgical approach, extent of resection, intraoperative dissection strategy, anesthesia, hemostasis, or postoperative care.
The study will evaluate three tissue types:
Fat flap tissue. Fibrotic tissue. Muscular tissue.
Fat tissue will be evaluated using standardized blocks measuring 1.25 cm × 1 cm × 1 cm, obtained from the surgically removed specimen. For fat tissue, the experimental design will include two electrocautery tips, two power settings, and two electrosurgical modes:
Blunt tip, 25 watts, cut Blend 2. Blunt tip, 25 watts, coagulation. Blunt tip, 50 watts, cut Blend 2. Blunt tip, 50 watts, coagulation. Utah tip, 25 watts, cut Blend 2. Utah tip, 25 watts, coagulation. Utah tip, 50 watts, cut Blend 2. Utah tip, 50 watts, coagulation.
For each of the eight fat-tissue combinations, three thermal measurements will be performed. Therefore, each participant may contribute up to 24 fat-tissue thermal measurements when sufficient fat tissue is available.
Histopathological samples will not be repeated for each thermal repetition. Instead, one representative histopathology sample will be submitted for each experimental combination, resulting in up to eight fat-tissue pathology samples per participant.
Fibrotic and muscular tissue will be evaluated only when included in the clinically indicated surgical specimen. Because these tissues are more limited, the experimental assessment will be restricted to 25 watts. For each tissue type, the following four combinations will be evaluated when tissue availability allows:
Blunt tip, 25 watts, cut Blend 2. Blunt tip, 25 watts, coagulation. Utah tip, 25 watts, cut Blend 2. Utah tip, 25 watts, coagulation.
For fibrotic and muscular tissue, three thermal measurements per combination will be performed when feasible. One representative pathology sample per combination will be submitted. These specimens will not be prepared as standardized small blocks; instead, pathology will assess thermal damage from the electrocautery cut margins or surfaces of the tissue removed from the patient during the clinically indicated procedure.
All thermal measurements will include:
Baseline temperature before electrocautery activation. Maximum temperature during electrocautery cutting. Temperature 10 seconds after cutting. Temperature 30 seconds after cutting.
Thermal measurements will be obtained using a FLIR C3-X thermal camera under standardized conditions. The thermal camera will be positioned at a fixed distance of 50 cm from the tissue. The emissivity setting will be 0.95. Reflected temperature will be set at 20°C. Operating room humidity will be recorded as 57%, and operating room temperature will be recorded as 22°C.
All pathology samples will be coded alphabetically before submission to the pathology assessor. The pathology assessor will remain blinded to the electrocautery tip, power setting, and electrosurgical mode used for each sample. The coding key will be stored separately by the principal investigator or study coordinator and will not be provided to the pathology assessor.
The primary objective is to determine which electrocautery tip, power setting, and electrosurgical mode are associated with lower thermal damage in explanted biopolymer-infiltrated tissue.
29 studies on the registry are indexed under Foreign Bodies; 8 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 19 observational studies indexed under Foreign Bodies.
Browse Foreign Bodies studies →Research Inc is the lead sponsor of 24 studies on the registry; 22 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be patients scheduled for clinically indicated surgical removal of gluteal biopolymer-infiltrated tissue. The surgical procedure will not be modified by study participation. Experimental thermal and histopathological assessments will be performed only on tissue already removed from the patient.
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.
Time frame: At histopathological assessment after ex vivo electrocautery cutting, day 0, the same day that the surgery
Maximum Temperature During Electrocautery Cutting
Highest temperature recorded during each ex vivo electrocautery cut using the FLIR C3-X thermal camera.
Time frame: During each ex vivo electrocautery cut. Day 0, during the surgical procedure
Temperature 10 Seconds After Electrocautery Cutting
Tissue temperature recorded 10 seconds after completion of each ex vivo electrocautery cut.
Time frame: 10 seconds after each ex vivo electrocautery cut. Day 0, during the surgical procedure
Temperature 30 Seconds After Electrocautery Cutting
Tissue temperature recorded 30 seconds after completion of each ex vivo electrocautery cut.
Time frame: 30 seconds after each ex vivo electrocautery cut. Day 0, during the surgical procedure
Histological Carbonization Score
Degree of carbonization at the electrocautery cut margin, classified as absent, mild, moderate, or severe by histopathological assessment.
Time frame: At histopathological assessment after ex vivo electrocautery cutting. day 0, the same day that the surgery
Histological Coagulative Necrosis
Presence and extent of coagulative necrosis adjacent to the electrocautery cut margin, assessed histologically and classified as absent, mild, moderate, or severe.
Time frame: At histopathological assessment after ex vivo electrocautery cutting. day 0, the same day that the surgery
Collagen Retraction Score
Histological degree of collagen retraction adjacent to the electrocautery cut margin, classified as absent, mild, moderate, or severe.
Time frame: At histopathological assessment after ex vivo electrocautery cutting. day 0, the same day that the surgery
Tissue Calcification Grade
Histological grade of tissue calcification, classified as absent, mild, moderate, or severe.
Time frame: At histopathological assessment after ex vivo electrocautery cuttin. day 0, the same day that the surgery
Thermal Damage According to Electrocautery Tip
Comparison of thermographic and histological thermal damage between blunt and Utah electrocautery tips
Time frame: During ex vivo testing and at histopathological assessment. day 0, the same day that the surgery
Thermal Damage According to Power Setting
Comparison of thermographic and histological thermal damage between 25-watt and 50-watt power settings in fat tissue.
Time frame: During ex vivo testing and at histopathological assessment. day 0, the same day that the surgery
Thermal Damage According to Electrosurgical Mode
Comparison of thermographic and histological thermal damage between cut Blend 2 and coagulation modes.
Time frame: During ex vivo testing and at histopathological assessment. day 0, the same day that the surgery
Correlation Between Thermographic Measurements and Histological Thermal Damage
Correlation between thermal measurements, including baseline temperature, maximum temperature during cutting, temperature at 10 seconds, and temperature at 30 seconds, and maximum histological depth of thermal damage.
Time frame: From ex vivo thermal assessment to histopathological assessmen. day 0, the same day that the surgery
Baseline Tissue Temperature
Temperature of the tissue sample immediately before electrocautery activation, measured using the FLIR C3-X thermal camera.
Time frame: Immediately before each ex vivo electrocautery cut. day 0, the same day that the surgery
Plan to share: No
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