Complications after surgery in obese patients: Prevention and treatment of wound infections and pain after surgery.Prospective, open, monocentric study to investigate tissue concentrations of antibiotics and pain medication sampled during a surgical intervention using microdialysis in obese patients.

Phase 1

Conditions: Prophylactic antibiotics, wound infections and pain associated with elective surgery in obese patients
MedDRA version: 14.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863
MedDRA version: 14.1Level: PTClassification code 10036410Term: Postoperative wound infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2012-004383-22-DE

Lead Sponsor: niversity of Leipzig

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Obese (BMI = 35 kg/m2)
-age = 18 years
-patients undergoing an abdominal surgery and needing a perioperative prophylactic antibiotic and analgesics
-Written informed consent of the patient
Control group:
- BMI = 18,5 kg/m² und BMI < 30 kg/m²
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

Exclusion Kriteria – Drug Group 1 (Linezolid, Meropenem and Paracetamol/Metamizol):
-Patients who have received the study medication within the 72 hours before surgery
-known allergic reactions, hypersensitivity or contra-indications to Propacetamol-HCl or Metamizol-Sodium, Carbapenem-Antibiotics, ß-Laktam-Antibiotics (e.g. Penicilline, Cephalosporine), Pyrazolone und Pyrazolidine
-sever liver insufficiency
-Patients with disorders of bone marrow functions (e.g. after treatment with cytostacics) or disorders of the hematopoiesis system
-genetic induced Glucose-6-phosphate dehydrogenase deficiency
-acute hepatic porphyria
-existing hypotony
-patients with phenylketonuria or hereditary fructose-intolerance
-within the previous tow weeks intake of drugs, which inhibit Monoaminooxidase A or B (e.g. Phenelzin, Isocarboxazid, Selegilin, Moclobemid)
-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)

Exclusion Kriteria – Drug Group 2 (Tigecyclin and Paracetamol/ Metamizol):
-Patients who have received the study medication within the 72 hours before surgery
-known allergic reactions, hypersensitivity or contra-indications to Propacetamol-HCl or Metamizol-Sodium, Tigecycline, Tetracycline Antibiotics
-sever liver insufficiency
-Patients with disorders of bone marrow functions or disorders of the hematopoiesis system
-genetic induced Glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis)
-acute hepatic porphyria
-existing hypotony
-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)

Exclusion Kriteria – Drug Group 3 (Cefazolin, Metronidazol and Paracetamol/Metamizol):
-Patients who have received the study medication within the 72 hours before surgery
-known allergic reactions, hypersensitivity or contra-indications to Propacetamol-HCl or Metamizol-Sodium, Cephalosporins, other Cephalosporins, 5-Nitroimidazoles
-sever liver insufficiency
-Patients with disorders of bone marrow functions or disorders of the hematopoiesis system
-genetic induced Glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis)
-acute hepatic porphyria
-existing hypotony
-compromised renal function (creatinine-clearance < 35 ml/min)
-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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The establishment of an optimized drug-dose-model based on tissue concentrations of antibiotics, analgesics and other substances in obese patients.;Secondary Objective: Study of wound infections and improvement of postoperative analgesics in obese and non-obese patients using the optimized drug-dose-model;Primary end point(s): 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). If a drug group consists of more than one antibiotic the data analyses of concentrations will be performed separately. ;Timepoint(s) of evaluation of this end point: Upto 8 hours after administration of study medication

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 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>Intake of analgesics after surgery<br>Duration of hospitalisation;Timepoint(s) of evaluation of this end point: Upto 8 hours after administration of study medication