Chlorhexidine gluconate or polyhexamethylene biguanide disc dressing to reduce the incidence of Central-Line-Associated Blood Stream Infection: a feasibility randomised controlled trial (the CLABSI trial)

摘要

Background: A number of antimicrobial impregnated discs to prevent central-line associated blood stream infection (CLABSI) are marketed but it is unclear which disc is most effective. Aim: To investigate the feasibility and safety of comparing two antimicrobial impregnated discs to prevent CLABSI. Methods: We conducted a single-centre, parallel group, randomised controlled trial in a 929-bed, tertiary referral hospital. Hospital in-patients requiring a peripherally inserted central catheter were randomised to chlorhexidine gluconate (CHG) or polyhexamethylene biguanide (PHMB) disc dressing group. Dressings were replaced every 7-days, or earlier, if clinically required. Participants were followed until device removal or hospital discharge. Feasibility outcomes included: proportion of potentially eligible participants who were enrolled; proportion of protocol violations; and proportion of patients lost to follow-up. Clinical outcomes were: CLABSI incidence, diagnosed by a blinded infection control practitioner; all cause BSI; and product-related adverse events. Findings: Of 143 patients screened, 101 (42%) were eligible. Five (3.5%) declined participation. There was one post-randomisation exclusion. Two (2%) protocol violations occurred in the CHG group. No patients were lost to follow-up. Three (3%) blood stream infections occurred; two (2%) were confirmed CLABSIs (one in each group) and one a mucosal barrier injury-related BSI. 1217 device days were studied; resulting in 1.64 CLABSI/1000 catheter days. One (1%) disc-related adverse events occurred in the CHG group. Conclusion: Disc dressings containg PHMB are safe to use for infection prevention at catheter insertion sites. An adequately powered trial to compare PHMB and CHG discs is feasible.