The objective of this study is to determine whether long term (5 days) postoperative (cefazolin) antibiotics will decrease the rate of infection following lower extremity tumor surgery, when compared to short term (24 hours) postoperative (cefazolin…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Musculoskeletal and connective tissue neoplasms
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Development of a surgical site infection within 12 months following the initial
surgical procedure.
Secondary outcome
Secondary objectives of this study are to determine the influence of the
antibiotic regimen on the development of antibiotic-related complications (ie:
gastrointestinal infections, fungal infections, etc.), functional outcomes and
quality of life, the rate of re-operations, oncological recurrence and/or
metastases , and mortality after one year.
Background summary
Endoprosthetic reconstruction after resection of a lower extremity bone tumor
is associated with a high risk of infection. Infection of tumor prostheses can
have detrimental consequences, ranging from the need to perform surgical
debridement to amputation of the affected limb. Antibiotics are administered
around the operation in an attempt to reduce the risk of infection. However, to
date, there is no consensus regarding the most effective antibiotic regimen.
Study objective
The objective of this study is to determine whether long term (5 days)
postoperative (cefazolin) antibiotics will decrease the rate of infection
following lower extremity tumor surgery, when compared to short term (24 hours)
postoperative (cefazolin) antibiotics.
Study design
Multicenter, blinded, randomized controlled trial, using a parallel two-arm
design.
Intervention
Long term (5 days) versus short term (24 hours) postoperative (cefazolin)
antibiotics.
Study burden and risks
All visits and examinations are part of routine patient care. There are no
additional risks associated with participation in this study other than
possible complications associated with the routine patient care (the use of the
approved and widely used antibiotics (cephalosporins)). A potential benefit of
the long-term regimen is a reduction in the risk of postoperative infection. A
potential risk of the long-term regimen is the development of side-effects and
of bacterial resistance.
Wellington Street North 193
Hamilton L8L 8E7
CA
Wellington Street North 193
Hamilton L8L 8E7
CA
Listed location countries
Age
Inclusion criteria
1) Males and females 12 years of age or older;
2) Primary bone malignancies or benign aggres sive tumors of the femur or tibia, soft-tissue sarcomas which have
invaded the femur or tibia, or oligometastatic bone disease of the femur or tibia in a patient expected to live at
least one year post-operatively;
3) Treatment by excision and en doprosthetic reconstruction*;
4) Provision of informed consent
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 antibiotics [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
7) Reconstruction to include allograft as well
8) Likely problems, in the judgement of the investigator, with maintaining
follow-up
9) Enrolled or previously randomized in a competing study
10)Patients who weigh less than or equal to 45kg
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54882.058.15 |