Effectiveness of testing hard-to-heal wounds for bacterial protease activity: a randomised clinical trial

Objective: The study aimed to evaluate whether using a point-of-care test for bacterial protease activity (BPA) to target antimicrobial dressing use can improve outcomes for hard-to-heal wounds and reduce cost. Method: Wounds asymptomatic for infection and testing positive for BPA were randomly assigned to two weeks' treatment with a silver antimicrobial dressing in addition to standard of care (SoC) (intervention group) or to SoC only (control group). The patient's outcomes were monitored for 12 weeks. Results: The study included 100 wounds. A reduction in annualised nursing resource of 29.0% (95% confidence interval (CI): 1.9-34.1) for hard-to-heal wounds was predicted for the intervention versus control group (44 +/- 25.10 intervention group nurse/clinic visits versus 62 +/- 31.23 control group nurse/clinic visits; p=0.034). The percentage of patients reporting problems reduced for all EQ5D-3L dimensions for the intervention group, with the largest reductions in `pain/ discomfort' (-36.2%) and `anxiety/depression' (-19.1%). Prescription of antibiotics fell by 45% for wound-related infections in the intervention group compared with the control group. In the intervention group the number of patients who did not receive a prescription was 37/50 (74%), nine (18%) patients received one prescription and four (8%) patients received two or more prescriptions. In the control group 29/50 (58%) patients did not receive a prescription, 12 (24%) received one prescription and nine (18%) patients received two or more prescriptions; p=0.068. Conclusion: The utility of the BPA test to reduce predicted annualised nursing time was demonstrated. The strong trend towards reduced antibiotic prescribing and improved quality of life for patients with wounds treated for BPA deserves further study. Declaration of interest: The study was sponsored by WOUNDCHEK Laboratories, with funding from Health Innovation Manchester and Innovate UK. The authors have no other conflicts of interest.