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Clinical Trials/DRKS00022838
DRKS00022838
Not yet recruiting
Phase 3

Antibiotic Prophylaxis for preventing infectious complications in Orthognathic Surgery - APOS

Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg0 sites1,420 target enrollmentMarch 29, 2021
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ConditionsK07.1K07.2Anomalies of jaw-cranial base relationshipAnomalies of dental arch relationship

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
K07.1
Sponsor
Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg
Enrollment
1420
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 29, 2021
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

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

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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