Trial document




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  DRKS00022838

Trial Description

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Title

Antibiotic Prophylaxis for preventing infectious complications in Orthognathic Surgery

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Trial Acronym

APOS

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URL of the Trial

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Brief Summary in Lay Language

Perioperative antibiotic prophylaxis (antibiotic administration during the surgical procedure) is a scientifically proven standard for preventing wound healing disorders after surgery. Based on studies, it has been shown that this infection prophylaxis is important to reduce complications in the healing process of the surgical wound and the tissues involved.
However, to date, there have been no studies showing that by extending the administration of antibiotics postoperatively (after surgery), postoperative wound healing disorders are significantly less likely to occur. Although there are no clear benefits or treatment guidelines, postoperative prolonged antibiotic administration is still commonly performed. These prolonged administrations can vary from hours to several days. However, there are also physicians and hospitals that completely avoid postoperative antibiotic administration.
It is important to note that frequent and prolonged use of antibiotics promotes the development of antibiotic resistance and side effects. Therefore, antibiotics should be used only when medically necessary. Otherwise, there is a risk that the effectiveness of antibiotics is no longer given as a result of antibiotic resistance and that life-threatening courses can occur during the treatment of infections that do occur.
The purpose of this study is to investigate whether patients undergoing orthognathic surgery without prolonged postoperative administration of antibiotics are more likely to develop postoperative wound healing disorders than patients with prolonged postoperative antibiotic administration.
Furthermore, we will investigate whether hospital stay is prolonged in patients who did not receive postoperative antibiotic prophylaxis and whether the type of treatment (with or without postoperative administration of antibiotics) has an impact on patients' health-related quality of life.
Ampicillin/sulbactam is an antibiotic (penicillin derivative/betalactamase inhibitor) that has been approved for more than 20 years. Ampicillin/Sulbactam is an established drug that is used, among other things, as standard in Germany for the treatment and prevention of bacterial infections in the mouth, head and neck. Its good efficacy and tolerability have already been proven in many clinical studies and on the basis of several years of experience in its use. If there is no penicillin intolerance, the application is harmless and has few side effects.
By conducting the planned clinical trial, we hope to obtain clear data regarding prolonged postoperative antibiotic administration in order to be able to make guideline-based recommendations in the future and to reduce unnecessary antibiotic administration.

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Brief Summary in Scientific Language

It is a constant debate among surgeons whether the use of prolonged postoperative antibiotic prophylaxis may reduce surgical site infection rates. As definitive treatment guidelines are still lacking, many surgeons continue to use broad-spectrum antibiotics, causing not only increased costs but also contributing to the potential for antibiotic resistance. Hence, there is an urgent need for an appropriately designed prospective clinical trial, to find out whether a prophylactic use of antibiotics after surgery actually decreases surgical site infections to a clinically relevant degree.
This study presents a multicenter, randomised, controlled, double-blinded, clinical trial with two parallel study arms to demonstrate that no postoperative antibiotic prophylaxis is not inferior to antibiotic prophylaxis with respect to surgical site infections in patients having undergone orthognathic surgery. The primary efficacy endpoint is defined as the occurrence of postoperative surgical site infections within 30 days of surgery. Secondary endpoints are further efficacy and subject-oriented parameters within 90 days after surgery. The entire trial is planned for 54 months, with an enrolment of 1420 patients over 39 months by 14 participating centers.
As a highly standardised procedure on an exceeding, healthy and young homogenous study population and identical processes all over the world, elective orthognathic surgery as clean-contaminated procedure, provides comparable intervention groups with balanced baseline characteristics, comparable surgical duration, even when performed within multiple centers. Therefore, evaluating antibiotic prophylaxis after orthognathic surgery will be of high scientific value representable for other surgical procedures.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00022838
  •   2021/03/29
  •   [---]*
  •   yes
  •   Approved
  •   AFmu-849/2020 , Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   2020-001397-30 
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Health Condition or Problem studied

  •   K07.1 -  Anomalies of jaw-cranial base relationship
  •   K07.2 -  Anomalies of dental arch relationship
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Interventions/Observational Groups

  •   No Antibiotic Prophylaxis; placebo application (Placebo sodium chloride (NaCl) solution 0,9 %; 1-1-1 iv.) after Orthognathic surgery with four days of duration
  •   Antibiotic Prophylaxis after Orthognathic surgery (Ampicillin/Sulbactam; Unacid® or generic product; 1/0.5g 1-1-1 iv.) with four days of duration
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver
  •   Placebo
  •   Prevention
  •   Parallel
  •   III
  •   No
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Primary Outcome

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).

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2021/04/01
  •   1420
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional 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.

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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.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg
    • Ms.  Katrin  Enk 
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  PD Dr. Dr.  Oliver  Ristow 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    • Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  PD Dr. Dr.  Oliver  Ristow 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.