Postoperative infection prevention MedDRA version: 16.1 Level: PT Classification code 10050861 Term: Limb prosthesis user System Organ Class: 10041244 - Social circumstances
Conditions
Interventions
Trade Name: Zinacef
Product Name: Zinacef
Product Code: Zinacef
Pharmaceutical Form: Concentrate and solvent for solution for infusion
Trade Name: Natriumklorid B. Braun 9 mg/ml infuusioneste, liuos
Sponsors
Tays
Eligibility
Inclusion criteria
Inclusion criteria: 1) Men and women of skeletal maturity (15 years of age or older); 2) Primary bone malignancies or benign aggressive tumors of the lower extremity; 3) Treatment by excision and endoprosthetic reconstruction; 4) Preoperative chemotherapy (non-compulsory); 5) Provision of informed consent Are the trial subjects under 18? yes Number of subjects for this age range: 5 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1) Methicillin-resistant Staphylococcus Aureus (MRSA), or Vancomycin Resistant Enterococcus (VRE) colonization*; 2) Allergy to study antibiotics Zinacef® (cefuroxime)]; 3) Skeletal immaturity**; 4) Upper extremity endoprosthetic reconstruction; 5) Prior surgery in the affected limb (excluding a biopsy); 6) Revision surgery or prior infection in the limb*** 7) Enrolled in a competing study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients undergoing surgical excision and endoprosthetic reconstruction of a lower extremity bone tumor, is there any difference in the effect of postoperative antibiotic regimens (24 hours vs. 5 days) on infection rate outcomes?;Secondary Objective: In patients surgically treated for bone tumors of the lower extremities followed by limb reconstruction using an endoprosthesis, what is the impact of the postoperative antibiotic regimen (24 hours vs. 5 days) on the development of antibiotic-related complications (ie: gastrointestinal infections, fungal infections, etc.) and on patient functional outcome and quality of life after one year? ;Primary end point(s): The primary study endpoint is the development of a deep surgical site infection (SSI) within 12 months following the initial surgery to treat a primary bone tumor of the lower extremities. ;Timepoint(s) of evaluation of this end point: Patients will be monitored regularly by the treating physician at 2 weeks, 4 weeks, 3 months, 6 months, 9 months, and 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary study endpoints include patients’ functional outcome and quality of life, as well as antibiotic-related complications.;Timepoint(s) of evaluation of this end point: 3 months, 6 months, 9 months, 1 year. | — |
Countries
Canada, Finland, United States
Contacts
Public ContactMinna Laitinen
Tampere University Hospital
Outcome results
None listed