Ex Vivo Thermal Damage Assessment During Electrocautery Cutting of Explanted Biopolymer-Infiltrated Tissue

NCT07765576 | Not Yet Recruiting

• 1 other identifier: 003
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At histopathological assessment after ex vivo electrocautery cutting, day 0, the same day that the surgery

Secondary Outcomes (11)

• Maximum Temperature During Electrocautery Cutting

  During each ex vivo electrocautery cut. Day 0, during the surgical procedure

• Temperature 10 Seconds After Electrocautery Cutting

  10 seconds after each ex vivo electrocautery cut. Day 0, during the surgical procedure

• Temperature 30 Seconds After Electrocautery Cutting

  30 seconds after each ex vivo electrocautery cut. Day 0, during the surgical procedure

• Histological Carbonization Score

  At histopathological assessment after ex vivo electrocautery cutting. day 0, the same day that the surgery

• Histological Coagulative Necrosis

  At histopathological assessment after ex vivo electrocautery cutting. day 0, the same day that the surgery

Other Outcomes (1)

• Baseline Tissue Temperature

  Immediately before each ex vivo electrocautery cut. day 0, the same day that the surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Inc: lead

Study Sites (1)

Clinica Bioderma

Medellín, Antioquia, 050022, Colombia

Location

Related Publications (9)

• 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

  BACKGROUND

• 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.

  PMID: 3786347 BACKGROUND

• Eslami-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.

  PMID: 36904554 BACKGROUND

• Chu 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.

  PMID: 31515867 BACKGROUND

• Contreras-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

• 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.

  PMID: 16936539 BACKGROUND

• Coiffman F. Alogenosis iatrogénica. Una nueva enfermedad. Cirugia Plastica Ibero-Latinoamericana. 2008;34(1). doi:10.4321/s0376-78922008000100002

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 33761195 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Explanted fat flaps, fibrotic tissue, and muscular tissue obtained during clinically indicated surgical removal of gluteal biopolymers. Fat samples will be prepared as standardized blocks measuring 1.25 cm × 1 cm × 1 cm. Fibrotic and muscular tissue will be evaluated only when included in the clinically indicated surgical specimen. No additional tissue will be removed solely for research purposes.

MeSH Terms

Conditions

Granuloma, Foreign-Body; Foreign-Body Reaction; Foreign Bodies

Condition Hierarchy (Ancestors)

Granuloma; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Inflammation

Central Study Contacts

Edison Osorio, MD, Plastic surgeon

CONTACT

+57 314 8644099; info@edisonosorio.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Aerospace medicine, MSc, PhD(c); Medical research director - clinical research

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): August 16, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)