Prophylaxis of postoperative surgical site infections MedDRA version: 20.0 Level: LLT Classification code 10032531 Term: Other specified bacterial infections in conditions classified elsewhere and of unspecified site System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Unacid
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Ampicillin
CAS Number: 69-53-4
Other descriptive name: AMPICILLIN
Concentration unit: mg milligram(s)
Con
Sponsors
Ruprecht-Karls-University Heidelberg, Medical Faculty rep. by University hospital and Commercial Managing Director
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -?Subject scheduled for elective, primary OS (bimaxillary or mandibular only approach) -?Age at study enrolment = 18 years =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: To evaluate further efficacy and subject-oriented parameters of no AP in comparison to AP;Primary end point(s): Occurrence of postoperative A1 SSI (superficial incisional) as defined by CDC/KISS [21, 25] ;Timepoint(s) of evaluation of this end point: within 30 days after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;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 | — |
Countries
Germany
Contacts
Public ContactCranio- Oral- Maxillofac Surgery
University Hospital Heidelberg
Outcome results
None listed