A comparative analysis of Prontosan versus saline in hard-to-heal lower limb ulcers using real-world data

Objective: Hard-to-heal lower limb ulcers (LLUs) impose substantial clinical and economic burdens. Prontosan Wound Irrigation Solution, Prontosan Wound Gel or Prontosan Wound Gel X (PSGX; B. Braun Medical AG, Switzerland) are established alternatives to saline and water for wound cleansing. This study compared wound healing, healthcare resource use and costs in patients treated with either PSGX or saline solution. Method: This retrospective cohort study used real-world data from adults with diabetic, venous or unspecified hard-to-heal LLUs treated with wound cleansing solutions in England, UK, between April 2007 and March 2020. Patients were identified from the Clinical Practice Research Datalink Aurum, linked to Hospital Episode Statistics, and Office for National Statistics death records. In an intention-to-treat analysis, those receiving PSGX were propensity score matched to saline-treated controls. Wound healing was assessed using prescription-based surrogate measures. Adjusted comparisons of all-cause healthcare costs and resource use over 12 months were performed, accounting for exposure year, region, and wound dressing. Results: Of the 60,140 patients with a wound cleansing prescription, 990 PSGX-treated patients and 8522 saline-treated patients met the inclusion criteria. The adjusted wound healing hazard ratio for patients treated with PSGX compared with matched saline controls was 0.92 (95% confidence interval (CI): 0.76, 1.11, p=0.4). The adjusted mean all-cause cost was £605 lower for PSGX treatment (–£605; 95% CI: –£1227, £45; p=0.058). PSGX-treated patients had fewer inpatient admissions (–0.44; 95% CI: –0.54, –0.35; p<0.001), outpatient attendances (–1.1; 95% CI: –1.3, –0.89; p<0.001), and primary care consultations (–2.5; 95%CI: –3.2, –1.9; p<0.001) in the first year of treatment. Conclusion: In this analysis, PSGX use was associated with reduced healthcare resource utilisation and lower costs compared with saline, with savings equivalent to 21 community nurse visits. These real-world findings underscore the potential for cost savings and highlight the complexities of evaluating wound care interventions using routine clinical data.