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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Maximum Histological Depth of Thermal Damage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Maximum Histological Depth of Thermal Damage
时间窗: 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.
次要结局
- 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)
- Collagen Retraction Score(At histopathological assessment after ex vivo electrocautery cutting. day 0, the same day that the surgery)
- Tissue Calcification Grade(At histopathological assessment after ex vivo electrocautery cuttin. day 0, the same day that the surgery)
- Thermal Damage According to Electrocautery Tip(During ex vivo testing and at histopathological assessment. day 0, the same day that the surgery)
- Thermal Damage According to Power Setting(During ex vivo testing and at histopathological assessment. day 0, the same day that the surgery)
- Thermal Damage According to Electrosurgical Mode(During ex vivo testing and at histopathological assessment. day 0, the same day that the surgery)
- Correlation Between Thermographic Measurements and Histological Thermal Damage(From ex vivo thermal assessment to histopathological assessmen. day 0, the same day that the surgery)
研究者
Brian Ramirez, MD, MSc
MD, Aerospace medicine, MSc, PhD(c); Medical research director - clinical research
Research Inc