Antibiotic Prophylaxis for preventing infectious complications in Orthognathic Surgery

Phase 3

Conditions: K07.1
K07.2
Anomalies of jaw-cranial base relationship
Anomalies of dental arch relationship

Registration Number: DRKS00022838

Lead Sponsor: Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 1420

Inclusion Criteria

1. Subjects scheduled for elective, primary Orthognathic surgery (bimaxillary or mandibular only approach)
2. = 18 years of age < 65 years of age
3. Ability of subject to understand character and individual consequences of the clinical trial
4. Subject with basic literacy skills and ability to complete standardised health related questionnaires
5. Written informed consent (must be available before enrolment in the study)
6. 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.

Exclusion Criteria

1. Known hypersensitivity against Ampicillin/Sulbactam, other beta-lactam antibiotics and/or penicillin (and penicillin derivatives)
2. 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)
3. Condition in which elective surgery is not applicable
4. Syndromal malformations
5. Known renal insufficiency
6. Known diabetes
7. Current Morbus Pfeiffer disease
8. Suffering from lymphatic leucaemia
9. Pregnancy or lactation
10. Inability to comply with study and/or follow-up procedures
11. Participation in another interventional trial.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of postoperative surgical site infections (SSI) as defined by the Centers for Disease Control and Prevention criteria (CDC) and the Krankenhaus-Infektions-Surveillance-System” (KISS) within 30 days after surgery (POD30).<br>

Secondary Outcome Measures

Name	Time	Method
1. Deep incisional SSI or organ or space surgical site infections as defined by the Centers for<br>Disease Control and Prevention criteria (CDC) and the Krankenhaus-Infektions-Surveillance-System” (KISS) within 90 days after surgery (POD90) <br>2. Systemic infections, defined as a systemic inflammatory response syndrome associated with a postoperative SSI consecutive to Orthognathic surgery<br>3. Length of hospital stay (LOS), defined as the number of days from the day of OS to the day of discharge<br>4. Participant’s health related quality of life (HRQoL), measured by SF-36 and OHIP-G 14 <br>5. Medication related adverse events, defined as gastrointestinal complications or allergic reactions due to antibiotic administrations.