E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylaxis of postoperative surgical site infections |
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E.1.1.1 | Medical condition in easily understood language |
Prophylaxis of postoperative surgical site infections |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10032531 |
E.1.2 | Term | Other specified bacterial infections in conditions classified elsewhere and of unspecified site |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate that no postoperative antibiotic prophylaxis is not inferior to antibiotic prophylaxis with respect to surgical site infections (SSI) in subjects having undergone OS. The primary hypothesis is that the SSI rate in subjects undergoing OS without postoperative antibiotic prophylaxis (no AP) is not clinically relevant higher than in subjects with postoperative antibiotic prophylaxis (AP |
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E.2.2 | Secondary objectives of the trial |
To evaluate further efficacy and subject-oriented parameters of no AP in comparison to AP |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-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. |
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E.4 | Principal exclusion criteria |
- 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurrence of postoperative A1 SSI (superficial incisional) as defined by CDC/KISS [21, 25] |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
within 30 days after surgery |
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E.5.2 | Secondary end point(s) |
1. Deep incisional (A2) and/or organ or space SSI (A3) as defined by CDC/KISS [21, 25] As an implant is used, a deep incisional (A2) or organ and space SSI (A3) may occur within 90 days after surgery according to CDC/KISS criteria [21, 25]. 2. Systemic infections, defined as a systemic inflammatory response syndrome associated with a postoperative SSI consecutive to OS. White blood cell Count, c-reactive Protein 3. LOS, defined as the number of days from OS to the day of discharge. 4. HRQoL, measured by SF-36 and OHIP-G-14 HRQoL is an important patient-oriented outcome and can be directly or indirectly influenced by SSI. 5. Non-severe medication related adverse events, defined as mild diarrhoea or skin rash due to antibiotic administrations.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. POD 90 2. BL, POD 4, POD 30 3.Day of discharge 4.BL, POD 4, POD 30, POD 90 5. BL, POD 0, POD 2, POD 4, POD 10, POD 30 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 14 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |