Efficacy and tolerance of a hydrocolloid dressing containing hyaluronic acid for the treatment of leg ulcers of venous or mixed origin.
OBJECTIVE
This study was aimed at comparing efficacy and tolerance of a new hydrocolloid dressing containing hyaluronic acid (HC + HA) to a reference hydrocolloid not containing hyaluronic acid (HC) in the treatment of leg ulcers of venous or mixed origin.


METHODS
This was an open, prospective study, randomized in parallel groups, in which 125 patients were enrolled and treated for up to 42 days. The primary efficacy criterion was the reduction of the wound area; other efficacy criteria were the condition of the wound bed, and of the surrounding skin, and presence and severity of symptoms such as pain and itching.


RESULTS
After 42 days of treatment the median reduction of ulcer area was -42.6% (95% confidence interval [CI]: -66.6; -5.7) and -31.0% (95% CI: -51.6; -8.8) in the HC + HA group and in the reference HC group, respectively. The difference between treatments was not statistically significant. A reduction > or = 90% of the initial ulcer area was seen in 15 patients in the HC + HA dressing group and in only seven patients in the HC dressing group. Changes in wound bed condition in the two groups were not significantly different, except for a more marked reduction of fibrinous tissue in the HC + HA dressing group (p = 0.04), at Day 28. Both treatments were well tolerated.


CONCLUSIONS
The HC + HA dressing was equally well tolerated and with a trend to be more effective than the reference HC dressing in the treatment of leg ulcers of venous or mixed origin. Further research is needed to confirm these findings.
Meaume
Sylvie
S
APHP Groupe Hospitalier Charles Foix, Service de Gérontologie 'l'Orbe', Ivry-sur-Seine, France. sylvie.meaume@cfx.ap-hop-paris.fr
Ourabah
Zohra
Z
Romanelli
Marco
M
Manopulo
Roberto
R
De Vathaire
Florent
F
Salomon
Denis
D
Saurat
Jean-Hilaire
JH
D000368:Aged; D047070:Bandages, Hydrocolloid; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000009:adverse effects / Q000494:pharmacology*; D008297:Male; D010146:Pain / Q000209:etiology; D059408:Pain Management; D011537:Pruritus / Q000209:etiology / Q000628:therapy; D012074:Remission Induction; D013997:Time Factors; D014647:Varicose Ulcer / Q000150:complications / Q000628:therapy*
D006820:Hyaluronic Acid