Foreign Bodies, Foreign-Body Reaction, Granuloma, Foreign-Body, Soft Tissue Disease, Thermal Injury Response
Conditions
Keywords
Biopolymer removal, Foreign body reaction, Electrocautery, Thermal injury, Histopathology, Ex vivo study
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.
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.
Interventions
None listed
Sponsors
Research Inc
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Histological Depth of Thermal Damage | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histological Carbonization Score | At histopathological assessment after ex vivo electrocautery cutting. day 0, the same day that the surgery | Degree of carbonization at the electrocautery cut margin, classified as absent, mild, moderate, or severe by histopathological assessment. |
| Histological Coagulative Necrosis | At histopathological assessment after ex vivo electrocautery cutting. day 0, the same day that the surgery | Presence and extent of coagulative necrosis adjacent to the electrocautery cut margin, assessed histologically and classified as absent, mild, moderate, or severe. |
| Collagen Retraction Score | At histopathological assessment after ex vivo electrocautery cutting. day 0, the same day that the surgery | Histological degree of collagen retraction adjacent to the electrocautery cut margin, classified as absent, mild, moderate, or severe. |
| Tissue Calcification Grade | At histopathological assessment after ex vivo electrocautery cuttin. day 0, the same day that the surgery | Histological grade of tissue calcification, classified as absent, mild, moderate, or severe. |
| Thermal Damage According to Electrocautery Tip | During ex vivo testing and at histopathological assessment. day 0, the same day that the surgery | Comparison of thermographic and histological thermal damage between blunt and Utah electrocautery tips |
| Thermal Damage According to Power Setting | During ex vivo testing and at histopathological assessment. day 0, the same day that the surgery | Comparison of thermographic and histological thermal damage between 25-watt and 50-watt power settings in fat tissue. |
| Thermal Damage According to Electrosurgical Mode | During ex vivo testing and at histopathological assessment. day 0, the same day that the surgery | Comparison of thermographic and histological thermal damage between cut Blend 2 and coagulation modes. |
| Correlation Between Thermographic Measurements and Histological Thermal Damage | From ex vivo thermal assessment to histopathological assessmen. day 0, the same day that the surgery | 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. |
| Maximum Temperature During Electrocautery Cutting | During each ex vivo electrocautery cut. Day 0, during the surgical procedure | Highest temperature recorded during each ex vivo electrocautery cut using the FLIR C3-X thermal camera. |
| Temperature 30 Seconds After Electrocautery Cutting | 30 seconds after each ex vivo electrocautery cut. Day 0, during the surgical procedure | Tissue temperature recorded 30 seconds after completion of each ex vivo electrocautery cut. |
| Temperature 10 Seconds After Electrocautery Cutting | 10 seconds after each ex vivo electrocautery cut. Day 0, during the surgical procedure | Tissue temperature recorded 10 seconds after completion of each ex vivo electrocautery cut. |
Countries
Colombia
Contacts
CONTACTEdison Osorio, MD, Plastic surgeon
Outcome results
None listed