Plain English Summary
Background and study aims
Infections are a serious complication of major surgery, especially when this involves implantation of artificial devices such as knee or hip joints. Orthopaedic surgery is one of the most common types of surgery in which artificial devices such as joint replacements are used. A common type of infection is from a bacterium called Staphylococcus aureus (S. aureus). A resistant sub-type of this bacteria type is MRSA, which is well known to cause major problems because it is resistant to many antibiotics. About 30% of healthy people have S. aureus in their nose, and sometimes on other parts of their body. Some infections occurring after surgery may result from bacteria on a patients’ own body spreading, and there is evidence that S. aureus spreading from sites such as the nose are important. At present, if MRSA is detected on a patient before they undergo surgery an eradication treatment regimen is routinely used, but this is not the case for other forms of S. aureus. It is quite difficult to effectively eradicate these bacteria before surgery, and the treatments required are quite inconvenient to patients. They involve applying ointment to the nose for 5 days, washing the body with antiseptics, gargling with an antiseptic mouthwash and changing bedsheets. A new treatment currently being investigated for the eradication of S. aureus in patients prior to surgery is one which uses a LASER. The treatment focuses a LASER on the area in the nose where S. aureus is typically found, and results suggest that it can increase the effectiveness of current eradication treatments. The LASER works by increasing the susceptibility of the bacteria to the existing treatments, making them more effective. The results of completed studies suggest the treatment is effective and safe, but large studies have not yet been carried out. The aim of this study is to see how efficient the current standard treatment is for patients prior to undergoing orthopaedic surgery, which doesn’t use the LASER. This study also aims to test the protocol that would be used for enrolling patients, treating them, and taking the samples needed in a trial of the LASER therapy. This study will not use the LASER. The results of this study will be used in future studies which will evaluate how effective the LASER is when added to the treatments currently used in NHS hospitals to treat S. aureus in the nose before surgery.
Who can participate?
Adults scheduled for elective implant surgery that are found to be colonised with S. aureus.
What does the study involve?
All participants colonised with S. aureus are given the current eradication treatment currently recommended in national guidelines. Participants are asked to carry out a 5-day home treatment regimen which includes using a nasal ointment, gargle mouthwash and a soap/shampoo substitute before they have orthopaedic implant surgery.
What are the possible benefits and risks of participating?
There may be potential benefits as patients on the study are screened and treated for MRSA and MSSA, current policy in NHS Scotland is to screen and treat for MRSA only. There is some evidence that eradicating MSSA in addition to MRSA prior to surgery reduces the risk of infection before surgery. There are no perceived risks for patients participating in this study.
Where is the study run from?
Royal Infirmary of Edinburgh (UK)
When is the study starting and how long is it expected to run for?
June 2015 to November 2016
Who is funding the study?
Selex ES
Who is the main contact?
1. Prof. T Walsh (scientific)
timothy.walsh@ed.ac.uk
2. Prof. H Simpson (scientific)
Hamish.Simpson@ed.ac.uk
3. Dr J Boyd (public)
julia.boyd@ed.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Timothy Walsh
ORCID ID
http://orcid.org/0000-0002-7376-8251
Contact details
Royal Infirmary of Edinburgh
Department of Critical Care
Little France Crescent
Edinburgh
EH16 2SA
United Kingdom
+44 (0)131 242 6395
timothy.walsh@ed.ac.uk
Type
Scientific
Additional contact
Prof Hamish Simpson
ORCID ID
Contact details
SU 303 Chancellor's Building
49 Little France Crescent
Edinburgh
EH16 4SB
United Kingdom
+44 (0)131 242 6644
Hamish.Simpson@ed.ac.uk
Type
Public
Additional contact
Dr Julia Boyd
ORCID ID
http://orcid.org/0000-0002-9872-3893
Contact details
Edinburgh Clinical Trials Unit
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
+44 (0)131 537 3842
julia.boyd@ed.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol version 3.2, 14 August 2015
Study information
Scientific title
Laser Assisted Staphylococcal ERadication prior to elective orthopaedic implantation surgery (LASER study): pilot study phase I
Acronym
LASER
Study hypothesis
This is a feasibility study. The trialists want to measure how common Staphylococcus aureus (S. aureus) colonisation is in patients undergoing orthopaedic surgery and how efficient the current treatment is for S. aureus eradication. The trialists also want to test the protocol they would use for enrolling patients, treating them, and taking the samples needed in a future trial involving LASER therapy as an adjunct to clearing S aureus colonisation prior to surgery.
Ethics approval
Ethics Committee South East Scotland REC 02, 12/06/2015, ref: 15/SS/0091.
Study design
Prospective single-centre non-blinded feasibility study
Primary study design
Observational
Secondary study design
Case series
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Orthopaedic patients presenting for elective implant surgery that are colonised with S. aureus
Intervention
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 be provided that includes day-by-day instructions for a 5-day treatment. This comprises:
1. Nose: Mupirocin 2% nasal ointment applied to the inner surface of each nostril (anterior nares) three times daily for 5 days. The participant should be able to taste mupirocin at the back of the throat after application.
2. Throat: Gargle mouthwash and oral hygiene with chlorhexidine gluconate 0.2% mouthwash solution twice daily for 5 days.
3. Body: Chlorhexidine gluconate 4% (Hibiscrub) solution as soap/shampoo substitute once daily for 5 days. Chlorhexidine solution must be kept in contact with the skin for at least 30 seconds and should be used as a shampoo at least twice in the 5 day period. An emollient and/or hair conditioner may be used if skin drying occurs. The skin should be moistened and the antiseptic solution applied thoroughly to all parts of the skin before rinsing in a bath or shower. Do not dilute in bath water as the concentration would be insufficient. A disposable sponge or flannel should be used to apply the antiseptic solution.
Intervention type
Drug
Phase
Phase I
Drug names
Mupirocin, chlorhexidine
Primary outcome measure
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 outcome measures
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
Overall trial start date
01/06/2015
Overall trial end date
30/11/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
50-100
Participant 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
Recruitment start date
20/10/2015
Recruitment end date
20/04/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Sponsor information
Organisation
University of Edinburgh
Sponsor details
ACCORD - R&D Management Suite
The Queen's Medical Research Institute
Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 3325
researchgovernance@ed.ac.uk
Sponsor type
University/education
Website
Organisation
NHS Lothian
Sponsor details
The Queen's Medical Research Institute
Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 3359
susan.shepherd@nhslothian.scot.nhs.uk
Sponsor type
Hospital/treatment centre
Website
http://www.nhslothian.scot.nhs.uk
Organisation
University of Edinburgh
Sponsor details
Sponsor type
Not defined
Website
Funders
Funder type
Industry
Funder name
Selex ES
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. T Walsh (timothy.walsh@ed.ac.uk).
Intention to publish date
30/11/2017
Participant level data
Available on request
Basic results (scientific)
See additional file ISRCTN28026496_BasicResults_05June17.docx
Publication list
Publication citations
Additional files
- ISRCTN28026496_BasicResults_05June17.docx Uploaded 26/06/2017