LASER Study - Pilot Study Phase 1: version 1, 18th March 2015
Research type
Research Study
Full title
LASER Assisted Staphylococcal ERadication prior to elective orthopaedic implantation surgery (LASER study): Pilot study Phase I
IRAS ID
177214
Contact name
Tim Walsh
Contact email
Duration of Study in the UK
0 years, 11 months, 27 days
Research summary
Around 25% 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 two PBLT treatments. We plan to carry out two pilot studies to provide important data on the design, feasibility and safety of trial procedures of the main study. This application relates to Phase I of the pilot study and does not involve use of the Photobiologic Laser.
Phase I – study the effectiveness of current NHS protocols for eradicating staphylococci prior to orthopaedic implant surgery. Current NHS protocols involve the use of nasal mupirocin and chlorhexidine mouthwash and soap. Patients will be recruited from the pre-op orthopaedic outpatients clinic over a 6 month period.
This study will establish likely recruitment rates, safety and acceptability of the existing decolonisation regimen, the decolonisation/recolonisation rates, and the protocol compliance rates. These data will enable the design of a subsequent parallel group RCT, and provide safety and acceptability data to justify proceeding to a trial.
REC name
South East Scotland REC 02
REC reference
15/SS/0091
Date of REC Opinion
12 Jun 2015
REC opinion
Further Information Favourable Opinion