JPRN-jRCTs032230078已完成Unknown
Development for certificated medical markers using safe pigments for precise marking on surgical field in the human body.
Maruoka Yutaka0 个研究点目标入组 5 人开始时间: 2023年5月17日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
Minor invasive (marking with pen under development), with intervention, single-center, prospective, open-label, single-arm study (planned number of patients: 5. Expected study end date: March 31, 2023). The observation periods were 1, 4, 8, and 12 weeks postoperatively to investigate wound healing, the presence or absence of tattoo scars, and the occurrence and frequency of serious adverse events. The results showed good penmanship and no adverse events were observed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age 00month old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients undergoing surgery (disease requiring tooth extraction, jaw deformity, jawbone cyst, jawbone tumor, oral mucosal tumor, jawbone fracture) at National Center for Global Health and Medicine Hospital Dentistry and Oral Surgery
- •2) Adult men and women over the age of 18
- •3) with written consent
- •4) Subjects who are able to comply with the rules during study participation and receive medical examinations stipulated in this protocol
排除标准
- •1) Patients who are deemed inappropriate by the attending physician.
- •2) Those who already have pigmentation in the marking area
- •3) Persons who may be allergic to the ingredients (ink) of the research equipment (surgical drawer)
研究者
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