A reduced multicomponent bandage compression system in the management of venous leg ulcers: a clinical evaluation.

Abstract

Objective: Lower limb assessment, patient adherence to treatment and timely initiation of compression therapy are major issues for most healthcare services managing patients with leg ulcers (LUs). Various guidelines recommend that if a patient has a LU and no 'red flag' symptoms, then 'mild' or 'reduced' compression therapy (20mmHg) is better than no compression while they await an ankle-brachial pressure index (ABPI), or if patients with a venous leg ulcer (VLU) cannot tolerate prescribed high compression therapy (40mmHg). The aim of this clinical study was to document the performance of a multicomponent bandage compression system applying reduced pressure in real-life practice, as recommended in national guidance. Method: A retrospective, multicentre, non-comparative clinical study was carried out within community settings in the UK. Eligible patients were consecutive adult outpatients with a VLU (or suspected VLU) treated with the evaluated compression system (UrgoKTwo Reduced; Laboratoires Urgo, France), after 'no red flags' for reduced compression therapy were identified. The primary endpoint was the rate of complete ulcer closure by week 12. Main secondary endpoints included time-to-heal in days, oedema resolution, patient adherence and local adverse events (AEs). Results: Data from 102 patients (35-99 years old, 60% female, 58% overweight or obese) who had been treated with the evaluated compression system for an average period of 50±32 days were included in this clinical study. The prescription of the compression system was justified for 84% of patients by poor tolerance of high compression, and for 16% by the absence of a complementary vascular examination (ABPI). UrgoStart Plus dressings (Laboratoires Urgo, France) were combined with the compression system in 43% of wounds, while antimicrobial dressings were frequently applied in cases of local wound infection. During the treatment period, patient adherence to compression therapy was rated 'very good' or 'good' in 99% of cases (wearing the compression bandages 24 hours a day until the next nurse visit). By the end of the treatment period, 75% of wounds healed, with a median time-to-heal of 45 days (interquartile range: 33 days, 63 days), 23% improved and 2% worsened. The highest wound closure rates were achieved in cases of recent wounds or wounds treated with the UrgoStart Plus treatment range (91% and 89%, respectively). The shortest healing times were observed with smaller wounds or those treated with UrgoStart Plus dressings (13 and 10 days sooner, respectively). By the final visit, oedema was resolved in 63% of patients who had oedema at baseline. Once their ulcer healed, 75% of patients received subsequent compression hosiery to prevent ulcer recurrence. Throughout the study period, only one AE was documented by the healthcare professionals: a local wound infection, unrelated to the compression system evaluated, but for which compression therapy was discontinued because of the associated pain. Conclusion: These findings are consistent with previous evidence available on this reduced compression system and support its use as a first-line treatment in patients with a suspected VLU until a full vascular assessment indicates that stronger compression is appropriate, as well as in patients who are unable to tolerate high compression therapy.