Efficacy of a silver lipidocolloid dressing on heavily colonised wounds: a republished RCT
Author(s) : I. Lazareth
- Objective : To assess the ability of a silver lipidocolloid contact layer to promote the healing process of venous leg ulcers (VLUs) presenting inflammatory signs, suggesting a heavy bacteria colonisation, and then delayed healing, in comparison with the same wound dressing not impregnated with silver salts.
- Methods: This was an open-labelled, randomised, controlled trial. VLU presenting at least 3 out of 5 clinical signs suggesting heavy bacterial colonisation were recruited. Patients were treated with contact-layer silver-dressing (CLS; Urgotul Silver [URGO Laboratories]) or contact-layer dressing (CL; Urgotul [URGO Laboratories]) for 4 weeks, then all treated ulcers were treated with CL for 4 additional weeks. Wound evaluation and area measurements were conducted weekly, during the first 4 weeks, and then at weeks 6 and 8. Main efficacy criterion was absolute wound area decrease (AD) at week 4 and week 8.
- Results: Patients (n=102) were randomised and treated. Ulcers were present for nearly 11 months on average; 65% were recurrent and mean area was 20.0±17.8cm². Almost 80% of the treated VLU were stagnating/aggravating with their previous treatment. By week 4, mean surface area decreased by 6.5±13.4cm² (median: 4.2cm²) and 1.3±9.0cm² (median: 1.1cm²) in CLS and CL groups, respectively (p=0.023). At week 8, median decrease was 5.9cm² vs 0.8cm² (p=0.002), with a wound percentage decrease of 48% and 5.6% (p=0.036). Median closure rate was 0.145cm²/day vs 0.044cm²/day (p=0.009) at week 4 and remained higher in the CLS group up to week 8, even after switching to CL dressing in these patients (p=0.001). Odds ratio (multinomial logistic regression) of the chance to reach a ≥40% wound area reduction was 2.7 (95%CI: I.I;6.7, p=0.038) for silver-treated ulcers. Dressing tolerance was good in both groups.
- Conclusion: A 4-week treatment with silver-releasing lipidocolloid contact layer promotes a sustained increase of closure rate of venous leg ulcers presenting inflammatory signs, suggesting a high bacterial load.
- Declaration of interest: This study was funded by a grant from URGO Laboratories. Dr Meaume and Dr Lazareth have served as paid speakers for URGO Laboratories. Dr Sauvadet and Dr Bohbot are employees of URGO Laboratories.