LASER Study - Phase II pilot study
Research type
Research Study
Full title
LASER Assisted Staphylococcal ERadication prior to elective orthopaedic implantation surgery (LASER study): Phase II pilot study
IRAS ID
189371
Contact name
Tim Walsh
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
0 years, 9 months, 17 days
Research summary
Around 30% of adults in the UK carry Staphylococcus aureus (SA). These individuals are known to have an increased risk of infection following surgery. There is evidence that removal or reduction in the number of organisms prior to surgery can decrease the risk of infections. However, the eradication procedures are only partly-or in- effective in many patients. In some cases poor compliance with the eradication regimen may be reason for this but we know that current treatments are not always effective at killing bacteria.
A potential therapy has been developed which we hope will improve the effectiveness of current treatments and lead to a reduction in infection rates following surgery. When Photobiologic Laser Potentiation Therapy (PBLT) is administered to the nose, a known reservoir of SA, the susceptibility of bacteria to antimicrobial killing increases and eradication rates are improved.
In a future randomised controlled trial we plan to compare the effectiveness of current NHS eradication protocols with those supplemented with PBLT. This pilot study will provide important data on the design, feasibility and safety of trial procedures of the main study. This application relates to Phase II of the pilot study and involves use of the Photobiologic Laser.
Phase II – study the safety, acceptability and effectiveness of PBLT for eradicating staphylococci prior to orthopaedic implant surgery. Current NHS protocols involve the use of nasal mupirocin and chlorhexidine mouthwash and soap. We will test PBLT both as a replacement for and in addition to nasal mupirocin. Patients will be recruited from the pre-op orthopaedic out-patients clinic over an 8 month period.
This study will establish the safety and acceptability of the PBLT treatment, the proportion of patients with decolonisation and recolonisation, and protocol compliance. These data will enable the design of a parallel group RCT, and provide safety and acceptability data to justify proceeding to a trial.
REC name
South East Scotland REC 02
REC reference
16/SS/0181
Date of REC Opinion
25 Nov 2016
REC opinion
Further Information Favourable Opinion