Clinical study in which patients with bone cancer in the leg and who are undergoing surgery to remove the tumor and reconstruct the leg using a metal implant are randomly assigned to 1 of 2 antibiotic regimens.

Phase 1

• Conditions: * Patients with a primary bone malignancy or soft-tissue sarcoma that has invaded a lower extremity bone that are undergoing surgical treatment to resect the tumor and functionally reconstruct the limb using a modular metallic and polyethylene endoprosthetic implant to replace the surgically resected bones and joints. * Development of a surgical site infection according to the guidelines established by the Centers for Disease Control and Prevention (CDC); MedDRA version: 20.0Level: PTClassification code 10064736Term: Antibiotic prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.1Level: LLTClassification code 10056641Term: Post procedural site wound infectionSystem Organ Class: 100000004862; MedDRA version: 20.1Level: PTClassification code 10068943Term: Limb reconstructive surgerySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10036894Term: Prophylactic antibiotic therapySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: PTClassification code 10005978Term: Bone lesion excisionSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: PTClassification code 10073235Term: Bone prosthesis insertionSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: PTClassification code 10006007Term: Bone sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004961-26-AT
• Lead Sponsor: McMaster University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-07
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1)Males and females 12 years of age or older;
2)Primary bone malignancies or benign aggressive tumors of the lower extremity, or soft-tissue sarcomas which have invaded the bone;
3)Treatment by excision and endoprosthetic reconstruction*; and
4)Provision of informed consent
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 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1)Current known Methicillin-Resistant Staphylococcus Aureus (MRSA), or Vancomycin Resistant Enterococcus (VRE) skin colonization*;
2)Documented anaphylaxis or angioedema to penicillin or the study antibiotic [cefazolin, or equivalent gram-positive coverage (i.e., cefuroxime)];
3)Prior surgery within the surgical field of the affected limb (excluding a biopsy)**;
4)Prior local infection within the surgical field of the limb**;
5)Current known immunologically-deficient disease conditions (not including recent chemotherapy) ***;
6)Known renal insufficiency with estimated creatinine clearance (eGRF) of less than 54 mL/min for drug clearance;
7)Reconstruction to include a structural allograft (bone transplant);
8)Likely problems, in the judgement of the investigator, with maintaining follow-up;
9)Enrolled or previously randomized in a competing study; and
10)Patients who weigh less than or equal to 45kg****
11) Pregnancy

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether a 5-day regimen of post-operative prophylactic antibiotics in comparison to the standard 24-hour regimen decreases the rate of surgical site infections after limb salvage surgery within 1-year of follow-up.;Secondary Objective: to evaluate whether the use of a 5-day regimen of post-operative prophylactic antibiotics in comparison to the standard 24-hour regimen in patients that are surgically treated for bone tumors of the lower extremity followed by limb reconstruction using an endoprostheses has an impact on (A) the development of antibiotic-related complications (such as gastrointestinal or fungal infections); (B) patient functional outcomes and quality of life; (C) the rate of re-operations; (D) the rate of oncologic recurrence and/or metastases; and (D) the rate of mortality after one year.;Primary end point(s): The development of a surgical site infection (SSI);Timepoint(s) of evaluation of this end point: within 12 months following the initial surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Functional outcomes, antibiotic-related complications, adverse events, serious adverse events, re-operations, complications of wound healing, tumor recurrence or metastasis, and mortality;Timepoint(s) of evaluation of this end point: Patient will participant one year post-operativ in all and we come to follow up visits at 2 week after, 6 Week, 3 months, 6 months, 9 months and 1 year