Aetiological treatment of venous leg ulcers with compression therapy: real-life outcomes with two different procedures

Abstract

Objective: To evaluate the healing outcomes and costs associated with the aetiological management of venous leg ulcers (VLUs) treated with recommended multicomponent bandages (MCBs) and short-stretch bandages (SSBs). Method: This observational study is a retrospective comparative study (Level 2b), based on the French administrative healthcare database (Système National des Données de Santé, SNDS). It includes patients treated from onset with reimbursed MCBs and SSBs for a VLU episode, between July 2018 and September 2020. Although other compression systems, such as long-stretch bandages, are commonly used for the treatment of VLUs, they are not recommended by health authorities in France and thus, were not considered for this study. A binomial regression model was performed to estimate the adjusted relative risk of wound closure rates at three months for each group, based on potential confounding factors including, notably, age, sex, key comorbidities, and wound dressing size. The mean healthcare cost was calculated for patients whose VLUs healed within the study period. Results: The reimbursement data (including prescribed compression systems and nursing care) of the 25,255 selected patients were analysed in the study. There were no significant differences between the MCBs and SSBs groups when considering patient characteristics. The healing rates after three months' treatment, were 42% and 35% (p<0.001) in the MCBs and SSBs groups, respectively. When adjusting the statistical model, the chance of healing at three months was still 12% higher with MCBs compared with SSBs (p<0.0001). The median healing time was estimated at 115 (interquartile range (IQR): 60–253) days in the MCB group versus 137 (IQR: 68–300) days in the SSBs group. The average treatment cost per patient with a healed ulcer was €2875±3647 in the MCB group and €3580±5575) in the SSBs group (p=0.0179), due to lower hospital stay and nursing costs in the MCB group. Differences in wound characteristics between the two groups cannot be totally excluded, due to the limited content of the database in terms of clinical data, but should have been addressed, to some extent, through the study selection criteria and the chosen regression model. Conclusion: In this study, this SNDS analysis seemed to confirm that the healing outcomes achieved in real-life with MCBs were in line with those reported in clinical trials, and superior to SSBs, which reinforces the current position from the guidelines.