﻿﻿﻿﻿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.
﻿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.


CONCLUSIONS
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).﻿﻿﻿.
Hospital Saint Joseph, Paris, France; Email: ilazareth@hospital-saintjoseph.org.
Isabelle
I
Lazareth
Sylvie
S
Meaume
Michele Lea
ML
Sigal-Grinberg
Patrick
P
Combemale
Thierry Le
TL
Guyadec
Anne
A
Zagnoli
Jean-Luc
JL
Perrot
Anne
A
Sauvadet
Serge
S
Bohbot