JPRN-jRCTs042200040招募中1 期
Surgical reconstruction using the hyper dry human drying amniotic membrane (HD-AM) of the otolaryngology field - SHDAMO
Takakura Hiromasa0 个研究点目标入组 60 人开始时间: 2020年8月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)age, The patients who relatively have good Patient.
- •2)overall status of(at the agreement acquisition)20 years old or older. (ECOG Performance Status is more than level 2.)
- •[Ear disease]
- •(1)Cholesteatoma
- •Patients who were operated for canal wall down tympanoplasty (without reconstruction of canal wall,or packing mastoid).
- •(2)Myringoplasty
- •Patients who have tympanic perforation.
- •(3)Skin graft on the auricle
- •Patients who have the auricle disease(carcinoma,etc.).
- •[sinonasal diseases]
- •(1)maxillary tumor
- •Adult patients who will receive a partial maxillectomy for the maxillary tumor.
- •(2)nasal cavity tumor
- •Patients who will receive the endoscopic resection for the nasal cavity tumor.
- •(3)Hypertrophic or Allergic rhinitis
- •Patients who will receive the endoscopic turbinectomy or mucosal cauterization of the inferior turbinate for hypertrophic or allergic rhinitis.
- •(4)Refractory frontal sinusitis, frontal mucocele or tumor in the frontal sinus.
- •Patients who will receive the endoscopic modified Lothrop - Draf3 procedure for refractory frontal sinusitis, frontal mucocele or tumor in the frontal sinus.
- •[Oral and laryngopharyngeal diseases]
- •Patients who are scheduled to have mucous membrane or skin defect due to head and neck surgery.
- •4)The patients whom it is judged to be available for observation,the testing that conformed to a study enforcement plan and a survey.
排除标准
- •Ear disease
- •(1)Cholesteatoma
- •Patients who were operated for canal wall up tympanoplasty (with reconstruction of canal wall, or packing mastoid)
- •(2)Myringoplasty & (3)Skin graft on the auricle
- •Bellow 2) to 8)
- •sinonasal diseases
- •(1)maxillary tumor
- •Patients who had already received the endoscopic sinus surgery, turbinectomy, mucosal cauterization of the inferior turbinate or a partial maxillectomy in the past
- •(2)nasal cavity tumor
- •Patients who had already received the endoscopic sinus surgery, turbinectomy, mucosal cauterization of the inferior turbinate or a partial maxillectomy in the past
- •(3)Hypertrophic or Allergic rhinitis
- •Patients who had already received the endoscopic sinus surgery, turbinectomy, mucosal cauterization of the inferior turbinate or a partial maxillectomy in the past
- •(4)Refractory frontal sinusitis, frontal mucocele or tumor in the frontal sinus
- •Patients who had already received the endoscopic sinus surgery, turbinectomy, mucosal cauterization of the inferior turbinate or a partial maxillectomy in the past
- •Oral and laryngopharyngeal diseases
- •Patients who are considered not to be required to compensate for mucocutaneous defects due to the surgical procedure.
- •2)The patients whom a doctor judged safely for study period if it was difficult hospital visiting and to come home.
- •3)The patients who complicate eye infection with activity.
- •4)The patients who plan the enforcement of eye operations for evaluation eyes effective during study period in (we assume the agreement acquisition study initiation).
- •5)For the group medicine of the planned drug (Xylocaine anesthetic agent, Achromycin) to use during study period, it is the patient with a history of the drug allergy.
- •6)The patients (saying that, however, the subjects who do not receive the study drug are possible) who participated in other studies or clinical studies within six months.
- •7)Pregnancy or the childbearing patients who may be pregnant or hope for pregnancy during study period or do not use appropriate contraception.
- •8)The patients who were judged to be inadequate as an object of this study in testing at agreement acquisition by doctor.
研究者
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