The Role of a Silver Releasing Lipido-colloid Contact Layer in Venous Leg Ulcers Presenting Inflammatory Signs Suggesting Heavy Bacterial Colonization: Results of a Randomized Controlled Study.

ABSTRACT

UNLABELLED Objective. Clinical interest of silver in the management of chronic wounds is not fully established. The main objective of this clinical study was to assess the ability of a new silver releasing lipido-colloid contact layer to promote the healing process of venous leg ulcers (VLU) presenting inflammatory signs suggesting a heavy bacteria colonization and then a delayed healing, in comparison to the same wound dressing not impregnated with silver salts. METHODS: This was an open-labeled, randomized, controlled trial. VLU presenting at least 3 out of 5 clinical signs suggesting heavy bacterial colonization were recruited. Patients were treated with contact layer silver dressing ([CLS], Restore® Contact Layer, Silver* (Hollister Wound Care, Libertyville, Ill) or contact layer dressing ([CL] Restore® Contact Layer**, Hollister Wound Care, Libertyville, Ill) for 4 weeks, then all treated ulcers were treated with CL for the 4 additional weeks. Wound evaluation and area measurements were conducted weekly during the first 4 weeks and then at week 6 and 8. Main efficacy criterion was absolute wound area decrease (AD) at week 4 and week 8. RESULTS: Patients (N = 102) were randomized and treated. Ulcers were present for nearly 11 months on average; 65% were recurrent and mean area was 20.0 ± 17.8 cm2. Almost 80% of the treated VLU were stagnating/aggravating with their previous treatment. By week 4, mean surface area decreased by 6.5 ± 13.4 cm2 (median 4.2 cm2) and 1.3 ± 9.0 cm2 (median 1.1 cm2) in CLS and CL groups, respectively (P = 0.023). At week 8, median decrease was 5.9 cm2 versus 0.8 cm2 (P = 0.002) with a wound percentage decrease of 47.9% and 5.6% (P = 0.036). Median closure rate was 0.145 versus 0.044 cm2/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 1.1 to 6.7; P = 0.038) for silver treated ulcers. Dressing tolerance was good in both groups. CONCLUSION: A 4-week treatment with silver releasing lipido-colloid contact layer promotes a sustained increase of closure rate of venous leg ulcers presenting inflammatory signs suggesting a high bacterial load. Also marketed as *Urgotul® Silver and **Urgotul®, Laboratoires Urgo, (France)..