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.

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. - Microdialysis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004383-22-DE

Enrollment

Unknown

Registered

2013-01-15

Start date

2013-05-13

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylactic antibiotics, wound infections and pain associated with elective surgery in obese patients MedDRA version: 14.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863 MedDRA version: 14.1 Level: PT Classification code 10036410 Term: Postoperative wound infection System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Linezolid Pharmaceutical Form: Solution for infusion INN or Proposed INN: Linezolid CAS Number: 165800-03-3 Other descriptive name: LINEZOLID Product Name: Meropenem Pharmaceutical Form

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): Area under the concentration-time-curve (AUC) for plasma Maximal concentration (Cmax) Cmax/MIC (MIC = minimal inhibitory concentration) Time to exceed MIC Concentration at the time of surgical suture AUCtissue/AUCplasma Relation PK/PD-Parameter (Pharmacokinetics/Pharmacodynamics) Half-life (t1/2) Concentration of the substances of interest in the tissue taken during surgery Incidence of wound infections postoperative pain scoring Intake of analgesics after surgery Duration of hospitalisation;Timepoint(s) of evaluation of this end point: Upto 8 hours after administration of study medication	—

Measure

Time frame

Secondary end point(s): Area under the concentration-time-curve (AUC) for plasma Maximal concentration (Cmax) Cmax/MIC (MIC = minimal inhibitory concentration) Time to exceed MIC Concentration at the time of surgical suture AUCtissue/AUCplasma Relation PK/PD-Parameter (Pharmacokinetics/Pharmacodynamics) Half-life (t1/2) Concentration of the substances of interest in the tissue taken during surgery Incidence of wound infections postoperative pain scoring Intake of analgesics after surgery Duration of hospitalisation;Timepoint(s) of evaluation of this end point: Upto 8 hours after administration of study medication

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Countries

Germany

Contacts

Public ContactClinical Trial Centre Leipzig

ZKS Leipzig - KKS

0049034116 254

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 20, 2026