Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY): A Multi-Center Randomized Controlled Study Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections with Endoprosthetic Replacements

• Conditions: Postoperative infection prevention; MedDRA version: 16.1Level: PTClassification code 10050861Term: Limb prosthesis userSystem Organ Class: 10041244 - Social circumstances; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-004447-23-FI
• Lead Sponsor: Tays

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-21
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1042

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified