EUCTR2020-001397-30-DE进行中（未招募）1 期
APOS study- Antibiotic Prophylaxis for preventing infectious complications in Orthognathic Surgery
Ruprecht-Karls-University Heidelberg, Medical Faculty rep. by University hospital and Commercial Managing Director0 个研究点目标入组 1,420 人开始时间: 2020年11月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-?Subject scheduled for elective, primary OS (bimaxillary or mandibular only approach)
- •-?Age at study enrolment = 18 years < 65 years of age
- •-?Ability of subject to understand character and individual consequences of the clinical trial
- •-?Subject with basic literacy skills and ability to complete standardised health related questionnaires
- •-?Written informed consent (must be available before enrolment in the study
- •- For women with childbearing potential and men capable of reproduction: agreement to remain abstinent (refrain from sexual intercourse) or use of acceptable contraceptive methods in accordance with CTFG recommendation during treatment period with IMP and for at least one day after the last dose of IMP. Women currently using hormonal contraception only, agree to use additional non-hormonal barrier method during and one day after treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1420
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Known hypersensitivity against Ampicillin/Sulbactam, other beta-lactam antibiotics and/or penicillin (and penicillin derivatives)
- •- Known hypersensitivity against per protocol proposed drugs for post-operative analgetic therapy (first and second line therapy, rescue medication): ibuprofen or diclofenac; metamizol; tilidin/naloxone or piritramid)
- •- Any condition in which elective surgery is not applicable
- •- Syndromal malformations
- •- Known renal insufficiency
- •- Known diabetes mellitus
- •- Pregnancy or lactation
- •- Inability to comply with study and/or follow-up procedures
- •- Participation in another interventional Trial
- •- Current Morbus Pfeiffer disease
- •- Suffering from lymphatic leucaemia
研究者
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