The use of point of care protease diagnostics to improve wound healing: A prospective case-controlled study

Forty patients with chronic ulcers (Intervention Group), treated at four Italian wound clinics were enrolled and treated based on the TIMEH principles. Therapy decisions were assisted by two qualitative lateral flow point of care (PoC) tests, WOUNDCHEKTM Bacterial Status and WOUNDCHEKTM Protease Status, that detect bacterial protease activity (BPA) and elevated host inflammatory protease activity (EPA) respectively. Outcomes were monitored for 30 days. The outcomes and treatments were compared with a Control Group that were not tested. The Control Group had significantly more trauma wounds, so all patients and those with trauma wounds removed were analysed separately. Using test results to inform treatment decisions was strongly associated with increased rates of healing and improvement, odds ratio 13.00, 95% CI 4.16-40.66, p<0.0001 (all data) or odds ratio 10.40, 95% CI 3.13-34.53, p=0.0001 (trauma wounds removed). Significantly more surgical debridement (all data p=0.0089, trauma wound removed p=0.0025), systemic antibiotics (all data p=0.0036, trauma wounds removed p=0.0005) and significantly less antiseptics (all data p=0.0001, trauma wounds removed p=0.0001) were used in the Intervention Group. The percentage of wounds positive for BPA or having EPA reduced over time and was associated with improving mean TIMEH scores in the Intervention Group, suggesting treatment modifications stimulated by testing had improved outcomes. The expeditious test results were useful in determining treatment choice, monitoring effectiveness of treatment and especially helpful in judicious use of advanced therapies and invasive surgical interventions. This study confirms using PoC tests for BPA and EPA can assist treatment decisions and improve healing.