Orthopaedic patients presenting for elective implant surgery that are colonised with S. aureus Infections and Infestations Staphylococcal infection, unspecified site
Conditions
Interventions
All participants colonised with S. aureus will receive the decolonisation regimen currently recommended and used for MRSA eradication in NHS Lothian and recommended in national guidelines. A pack will
Sponsors
University of Edinburgh
NHS Lothian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is scheduled for elective implant surgery 2. Patient is attending pre-operative assessment clinic within 8-21 days of planned surgery 3. Patient has confirmed nasal colonisation with S. aureus (MSSA or MRSA) after pre-operative assessment using a rapid PCR test for MRSA and MSSA
Exclusion criteria
Exclusion criteria: 1. Patient with allergy or other contraindication to mupirocin or chlorhexidine treatment 2. Patient known to have mupirocin or chlorhexidine resistant SA 3. Patient unable to wait the 3-4 hours for the SA screening result 4. Patients in whom microbiological treatment for SA other than decolonisation is planned prior to hospital admission for surgery 5. Patients receiving antibiotics in the last 2 weeks or planned to receive antibiotics prior to surgery (excluding routine peri-operative antibiotic prophylaxis) 6. Patient scheduled to receive joint revision surgery due to infection 7. Patient lives too far from the hospital to be followed-up for microbiological sampling 8. Patient aged <16 years 9. Pregnancy or breastfeeding 10. No informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 05/06/2017: Proportion of participants cleared of nasal SA at 48-96 hours after completing current eradication regimens for S. aureus Previous primary outcome measures: Proportion of participants positive for nasal S. aureus 48-96 hours post eradication regimen as determined by microbial analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/06/2017: Feasibility outcomes 1. Consent rates as proportion of eligible participants 2. Recruitment rates 3. Protocol compliance rates Clinical outcomes 1. Clearance rates of SA from all 3 sampled sites at 48-96 hours after completing current eradication regimens for MRSA. 2. Clearance rates of SA from all 3 sampled sites at hospital admission (pre-surgery) after completing current eradication regimens for MRSA. 3. Clearance rates of SA from all 3 sampled sites at hospital discharge (post-surgery) after completing current eradication regimens for MRSA. 4. Clearance rates of SA from all 3 sampled sites at 6 weeks follow-up after surgery after completing current eradication regimens for MRSA. 5. Adverse event and serious adverse event rates reported in phase I and II of pilot Previous secondary outcome measures: Feasibility outcomes: 1. Consent rates as proportion of eligible patients 2. Recruitment rates 3. Protocol compliance rates Clinical outcomes: 1. Clearance rates of S. aureus from all 3 sampled sites at 48-96 hours after completing current eradication regimens 2. Clearance rates of S. aureus from all 3 sampled sites at hospital admission (pre-surgery) after completing current eradication regimens 3. Clearance rates of S. aureus from all 3 sampled sites at hospital discharge (post-surgery) after completing current eradication regimens 4. Clearance rates of S. aureus from all 3 sampled sites at 6 weeks follow-up after surgery after completing current eradication regimens 5. Adverse event and serious adverse event rates 6. Rate of HAIs at 6 weeks post-surgery 7. Hospital length of stay; 6 week follow-up measures 8. Rates of mupirocin resistance at baseline 9. Rates of biofilm forming S. aureus at baseline | — |
Countries
United Kingdom
Contacts
Public ContactJulia Boyd
Outcome results
None listed