APOS study- Antibiotic Prophylaxis for preventing infectious complications in Orthognathic Surgery
- Conditions
- Prophylaxis of postoperative surgical site infectionsMedDRA version: 20.0Level: LLTClassification code 10032531Term: Other specified bacterial infections in conditions classified elsewhere and of unspecified siteSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2020-001397-30-DE
- Lead Sponsor
- Ruprecht-Karls-University Heidelberg, Medical Faculty rep. by University hospital and Commercial Managing Director
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1420
-?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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method