Evaluating The Use of Silver-coated Segmental Limb-Salvage Implants on the Risk of Surgical Site Infection: A Multi-centre Prospective Randomized Controlled Trial.
Not Applicable
- Conditions
- InfectionSurgery - Surgical techniquesSurgery - Other surgeryInfection - Studies of infection and infectious agentsInjuries and Accidents - FracturesInjuries and Accidents - Other injuries and accidentsMusculoskeletal - Other muscular and skeletal disordersCancer - BoneCancer - Sarcoma (also see 'Bone') - soft tissueCancer - Other cancer types
- Registration Number
- ACTRN12623000769684
- Lead Sponsor
- ife Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 111
Inclusion Criteria
• Require segmental bone reconstruction of the distal femur following trauma, implant failure or resection of primary or secondary musculoskeletal malignancy
• Willing and able to provide informed consent for the trial
• Males and females 18 years or older
• Life expectancy > 12 weeks
• Medically fit for surgery
Exclusion Criteria
Patients under 18 years of age
• Patients without the cognitive ability to understand the research
• Patients who refuse consent or elect to withdraw from the study
• Patients with untreatable metastatic disease or a life expectancy under 12 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of this study is to assess surgical site infection (SSI) prospectively by qualified medical or nursing staff, with the presence or absence of infection recorded at 2, 5, 14, 42 days, 6 months, 1 year and 2 years postoperatively. [ 2, 5, 14, & 42 (+/-2) days, 6 months, 1 year and 2 years postoperatively across all patient strata groups, or at any time a clinical indication of infection arises as determined by qualified medical staff. ]
- Secondary Outcome Measures
Name Time Method