KCT0006111已完成未知
Investigator-initiated trials to confirm determination of effectiveness evaluation method and initial safety of Patient-Specific Implants for ear reconstruction (TnR BellaPore-E) for laterality macrotia on patients
Yonsei University Health System, Gangnam Severance Hospital0 个研究点目标入组 5 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
- Validity results The primary variable, ear recovery rate, ranged from 146 to 177%, and among the secondary variables, the ear recovery rate immediately after surgery compared to normal ear was evaluated from 216 to 246%, and the ear recovery rate at 48 weeks compared to immediately after surgery was evaluated from 61 to 77%. The satisfaction evaluation of the appearance by independent evaluators was 4 to 6 points (5.2) for evaluators 1 and 3 to 6 points (4.6) for evaluators 2, and the satisfaction evaluation results of the study subjects were 8 to 10 points (9.2). 2. Safety results As a result of safety evaluation, there were no significant abnormal reactions, and no significant abnormal case were observed. There were patients whose wound dehiscence were observed after surgery, but they were treated with resuture or conservative treatment.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •Criteria for selecting research subjects
- •1) Adults between 19 and 65 years of age
- •2) A person who does not have clinically significant abnormalities in a laboratory examination prior to surgery
- •3) Patients with external microtia who require surgical treatment under the judgment of the tester
- •4) A person who has a defect in part of the ear due to congenital malformation such as microtia;
- •5) Type II, III according to the classification of Tanzer's ears.
- •6) A person with a general anesthetic condition
- •7) A person who has been confirmed negatively in the pregnancy test and agrees to be contraceptive during the clinical trial period
- •8) A person who voluntarily agrees to the clinical trial and is willing and able to comply with the test plan.
排除标准
- •Criteria for excluding research subjects
- •1) Pregnant or breastfeeding
- •2) Patients with untreated ear trauma at the time of screening
- •3) Patients who are contaminated with open trauma, etc. at the time of screening
- •4) Patients with unhealed inflammation, granulomatosis, and infection at the time of screening
- •5) Patients with acute inflammation and carcinoma in the surgical field at the time of screening
- •6) Patients with bilaterality microtia at the time of screening
- •7) Patients with immune diseases including acquired immunodeficiency at the time of screening
- •8) Patients who received local hormone therapy within three months at the time of screening
- •9) Patients who have hematological diseases or tend to bleed at the time of screening;
- •10) Patients who have or are scheduled to have a history of therapeutic radiation irradiation of the craniocervical, including
- •the operating department, at the time of screening;
- •11) Patients who need to use steroids for a long period of time at the time of screening
- •12) A person who is allergic to polycaprolactone, a component of medical devices used in this clinical trial
- •13) Those who participated in other clinical trials at the time of screening and within the previous three months
- •14) Other researchers determined that the clinical trial was inappropriate
- •15) A person who takes a blood coagulant, steroids, immunosuppressant, etc. that may affect clinical outcomes;
- •16) A person whose pregnancy test results are positive (Only those who are confirmed to be negative may participate in the study).
研究者
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