Thermal Injury ResponseTHERM-BIOPOLNCT07765576
Ex Vivo Thermal Damage Assessment During Electrocautery Cutting of Explanted Biopolymer-Infiltrated Tissue
An observational study of Thermal Injury Response and Soft Tissue Disease, run by Research Inc at 1 site in Colombia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Thermal Injury Response, Soft Tissue Disease, Granuloma, Foreign-Body
- How many people
- 50 participants
- Where
- 1 siteColombia
- Study dates
- 16 Aug 2026to 1 Nov 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
- Specimens that cannot be processed within the predefined time window after explantation.
- Any situation in which the surgeon determines that research handling of the specimen could interfere with clinical care, pathology required for patient management, or institutional tissue handling policies.
- Lack of adequate thermographic recording due to technical failure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site
Clinica Bioderma
Medellín, Antioquia, 050022
Edison Osorio, MD, Plastic surgeon, +57 314 8644099, info@edisonosorio.com
Edison Osorio, MD, plastic surgery
About this study
Official title: Prospective Ex Vivo Evaluation of Thermal Damage in Explanted Fat, Fibrotic, and Muscular Tissue From Patients Undergoing Surgical Removal of Gluteal Biopolymers Using Blunt Versus Utah Electrocautery Tips
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Thermal Injury Response, Soft Tissue Disease, Granuloma, Foreign-Body, Foreign-Body Reaction, Foreign Bodies
- Keywords
- Biopolymer removal, Foreign body reaction, Electrocautery, Thermal injury, Histopathology, Ex vivo study
- Medical subject headings
- Granuloma, Foreign-Body, Foreign-Body Reaction, Foreign Bodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Clinically Indicated Gluteal Biopolymer Removal | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At histopathological assessment after ex vivo electrocautery cutting, day 0, the same day that the surgery
Secondary outcomes (11)
Maximum Temperature During Electrocautery Cutting
Highest temperature recorded during each ex vivo electrocautery cut using the FLIR C3-X thermal camera.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From ex vivo thermal assessment to histopathological assessmen. day 0, the same day that the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start16 Aug 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Thermal Injury ResponseStudies of the same condition, open and under way.
- More trials run by Research IncThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Brian Ramirez, MD, MSc, Research Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765576
- Sponsor's protocol ID
- 003
- Acronym
- THERM-BIOPOL
- Status last verified
- Aug 2026
- First submitted
- 11 Jun 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
OSORIO LONDOÑO E, MUÑOZ RÍOS M. Redistribución de biopolímeros en glúteos según hallazgos imagenológicos en resonancia magnética. Cirugía Plástica Ibero-Latinoamericana. 2025;51:415-21. doi:10.4321/s0376-78922025000400010
Lukas SE, Mendelson JH, Benedikt RA, Jones B. EEG alpha activity increases during transient episodes of ethanol-induced euphoria. Pharmacol Biochem Behav. 1986 Oct;25(4):889-95. doi: 10.1016/0091-3057(86)90403-x.
PubMed 3786347Eslami-Kaliji F, Hedayat Nia N, Lakey JRT, Smink AM, Mohammadi M. Mechanisms of Foreign Body Giant Cell Formation in Response to Implantable Biomaterials. Polymers (Basel). 2023 Mar 6;15(5):1313. doi: 10.3390/polym15051313.
PubMed 36904554Chu C, Liu L, Rung S, Wang Y, Ma Y, Hu C, Zhao X, Man Y, Qu Y. Modulation of foreign body reaction and macrophage phenotypes concerning microenvironment. J Biomed Mater Res A. 2020 Jan;108(1):127-135. doi: 10.1002/jbm.a.36798. Epub 2019 Oct 6.
PubMed 31515867Contreras-Díaz BR, Córdova-Gómez A, Rubio-Gómez L, Contreras-Ruiz Velasco R. Enfermedad por modelantes, síndrome autoinmune inducido por adyuvantes y otras enfermedades de la vanidad. Cirujano General. 2021;43(4). doi:10.35366/109126
Broder KW, Cohen SR. An overview of permanent and semipermanent fillers. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):7S-14S. doi: 10.1097/01.prs.0000234900.26676.0b.
PubMed 16936539Coiffman F. Alogenosis iatrogénica. Una nueva enfermedad. Cirugia Plastica Ibero-Latinoamericana. 2008;34(1). doi:10.4321/s0376-78922008000100002
Oliveros C, Pérez Rivera F, Betti Kraemer G, Cordero De Oliveros MD, Fernández Romero J, Medrano Ramírez G, et al. Disease caused by permanent synthetic fillers FILACP Biomaterials Committee expert group recomendations. Cirugia Plastica Ibero-Latinoamericana. 2022 Jan 1;48(3):287-303. doi:10.4321/S0376-78922022000300006
Castro CM, Rios CA, Lopez CA, Ospina ML, Ortiz Y. Adverse effects of modeling substances in Cali, Colombia. Biomedica. 2021 Mar 19;41(1):123-130. doi: 10.7705/biomedica.5707. English, Spanish.
PubMed 33761195
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Ex Vivo Evaluation of Thermal Damage in Explanted Fat, Fibrotic, and Muscular Tissue From Patients Undergoing Surgical Removal of Gluteal Biopolymers Using Blunt Versus Utah Electrocautery Tips
- ClinicalTrials.gov ID
- NCT07765576
- Acronym / sponsor ID
- THERM-BIOPOL / 003
- Conditions
- Thermal Injury Response, Soft Tissue Disease, Granuloma, Foreign-Body, Foreign-Body Reaction, Foreign Bodies
- Keywords
- Biopolymer removal, Foreign body reaction, Electrocautery, Thermal injury, Histopathology, Ex vivo study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 14 Aug 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Clinically Indicated Gluteal Biopolymer Removal | – | –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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Specimens that cannot be processed within the predefined time window after explantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximum Histological Depth of Thermal Damage
Time frame: At histopathological assessment after ex vivo electrocautery cutting, day 0, the same day that the surgery
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.
11 secondary outcomes
Maximum Temperature During Electrocautery Cutting
Time frame: During each ex vivo electrocautery cut. Day 0, during the surgical procedure
Temperature 10 Seconds After Electrocautery Cutting
Time frame: 10 seconds after each ex vivo electrocautery cut. Day 0, during the surgical procedure
Temperature 30 Seconds After Electrocautery Cutting
Time frame: 30 seconds after each ex vivo electrocautery cut. Day 0, during the surgical procedure
Histological Carbonization Score
Time frame: At histopathological assessment after ex vivo electrocautery cutting. day 0, the same day that the surgery
Histological Coagulative Necrosis
Time frame: At histopathological assessment after ex vivo electrocautery cutting. day 0, the same day that the surgery
Collagen Retraction Score
Time frame: At histopathological assessment after ex vivo electrocautery cutting. day 0, the same day that the surgery
Tissue Calcification Grade
Time frame: At histopathological assessment after ex vivo electrocautery cuttin. day 0, the same day that the surgery
Thermal Damage According to Electrocautery Tip
Time frame: During ex vivo testing and at histopathological assessment. day 0, the same day that the surgery
Thermal Damage According to Power Setting
Time frame: During ex vivo testing and at histopathological assessment. day 0, the same day that the surgery
Thermal Damage According to Electrosurgical Mode
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
Time frame: From ex vivo thermal assessment to histopathological assessmen. day 0, the same day that the 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 14 Aug 2026.
- BackgroundOSORIO LONDOÑO E, MUÑOZ RÍOS M. Redistribución de biopolímeros en glúteos según hallazgos imagenológicos en resonancia magnética. Cirugía Plástica Ibero-Latinoamericana. 2025;51:415-21. doi:10.4321/s0376-78922025000400010
- Background: PubMed 3786347Lukas SE, Mendelson JH, Benedikt RA, Jones B. EEG alpha activity increases during transient episodes of ethanol-induced euphoria. Pharmacol Biochem Behav. 1986 Oct;25(4):889-95. doi: 10.1016/0091-3057(86)90403-x.
- Background: PubMed 36904554Eslami-Kaliji F, Hedayat Nia N, Lakey JRT, Smink AM, Mohammadi M. Mechanisms of Foreign Body Giant Cell Formation in Response to Implantable Biomaterials. Polymers (Basel). 2023 Mar 6;15(5):1313. doi: 10.3390/polym15051313.
- Background: PubMed 31515867Chu C, Liu L, Rung S, Wang Y, Ma Y, Hu C, Zhao X, Man Y, Qu Y. Modulation of foreign body reaction and macrophage phenotypes concerning microenvironment. J Biomed Mater Res A. 2020 Jan;108(1):127-135. doi: 10.1002/jbm.a.36798. Epub 2019 Oct 6.
- BackgroundContreras-Díaz BR, Córdova-Gómez A, Rubio-Gómez L, Contreras-Ruiz Velasco R. Enfermedad por modelantes, síndrome autoinmune inducido por adyuvantes y otras enfermedades de la vanidad. Cirujano General. 2021;43(4). doi:10.35366/109126
- Background: PubMed 16936539Broder KW, Cohen SR. An overview of permanent and semipermanent fillers. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):7S-14S. doi: 10.1097/01.prs.0000234900.26676.0b.
- BackgroundCoiffman F. Alogenosis iatrogénica. Una nueva enfermedad. Cirugia Plastica Ibero-Latinoamericana. 2008;34(1). doi:10.4321/s0376-78922008000100002
- BackgroundOliveros C, Pérez Rivera F, Betti Kraemer G, Cordero De Oliveros MD, Fernández Romero J, Medrano Ramírez G, et al. Disease caused by permanent synthetic fillers FILACP Biomaterials Committee expert group recomendations. Cirugia Plastica Ibero-Latinoamericana. 2022 Jan 1;48(3):287-303. doi:10.4321/S0376-78922022000300006
- Background: PubMed 33761195Castro CM, Rios CA, Lopez CA, Ospina ML, Ortiz Y. Adverse effects of modeling substances in Cali, Colombia. Biomedica. 2021 Mar 19;41(1):123-130. doi: 10.7705/biomedica.5707. English, Spanish.
- Individual participant dataSharing planned: No
Related trials for Thermal Injury Response
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Recruiting
Impact of Indoor Overheating on Physiological Strain in Children
Heat Stress, Physiological Stress
Not yet recruitingObservational study
Surgical Critical Care Initiative (SC2i) Tissue and Data Acquisition Protocol (TDAP) in Burn Patients Improving the Robustness and Generalizability of Post-burn Sepsis Prediction With the Post-Burn Sepsis Digital Twin. Group 1
Sepsis, Burn Injury
Not yet recruitingObservational study
TDAP in Burn Patients (Group 2)
Sepsis, Burn Injury
Enrolling by invitationEarly Phase 1
Evaluation of In-Vitro Cryo Therapeutic Protocols on Human Cell Samples (TWH-CRYO-001)
Cellular Injury and Post-Cryogenic Recovery, Cryogenic Cellular Stress
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thermal Injury Response and Soft Tissue Disease, run by Research Inc at 1 site in Colombia.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 14 Aug 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 Colombia. 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 Edison Osorio, MD, Plastic surgeon (+57 314 8644099, info@edisonosorio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Histological Depth of Thermal Damage (time frame: At histopathological assessment after ex vivo electrocautery cutting, day 0, the same day that the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07765576, which also lists 9 linked publications.
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 14 Aug 2026.