Perioperative complications in obese and non-obese patients: Prevention and treatment of wound infections and post-operative pain.Prospective, open, monocentric study to investigate perioperative tissue concentrations of antibiotics and regional analgesics using microdialysis in obese and non-obese patients.
Phase 3
- Conditions
- MedDRA - 10054711 (Postoperative pain)MedDRA - 10036410 (Postoperative wound infection)T81.4Infection following a procedure, not elsewhere classified
- Registration Number
- DRKS00004776
- Lead Sponsor
- Klinik und Poliklinik für Anästhesiologie und IntensivtherapieUniversitätsklinikum Leipzig AöR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 125
Inclusion Criteria
BMI = 18.5 kg/m² and BMI < 30 kg/m²
- age = 18 years
- patients undergoing an abdominal surgery and needing a perioperative prophylactic antibiotic and analgesics
- Written informed consent of the patient
Exclusion Criteria
- Patients who have received the study medication within the 72 hours before surgery
- known allergic reactions or contra-indications to any of the study medications
- pregnant or breast-feeding women (positive pregnancy test for pre-menopausal women)
- participation in another interventional AMG study (studies falling in the jurisdiction of German Drug Law)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The area under the concentration-time-curve (AUC0-8) of the investigated antibiotics in the interstitial fluid from patients of one of the drug groups (1 to 3). Samples will be taken up to 8 hours after start of study medication. If a drug group consists of more than one antibiotic the data analyses of concentrations will be performed separately.
- Secondary Outcome Measures
Name Time Method All concentrations mentioned below will be investigated in the interstitial fluid as well as in plasma (if not otherwise specified).<br>- Area under the concentration-time-curve (AUC) for plasma<br>- Maximal concentration (Cmax) <br>- Cmax/MIC (MIC = minimal inhibitory concentration) <br>- Time to exceed MIC <br>- Concentration at the time of surgical suture <br>- AUCtissue/AUCplasma Relation<br>- PK/PD-Parameter (Pharmacokinetics/Pharmacodynamics)<br>- Half-life (t1/2) <br>- Concentration of the substances of interest in the tissue taken during surgery <br>- Incidence of wound infections <br>- postoperative pain scoring<br>Samples will be taken up to 8 hours after start of study medication.