title: RCT to evaluate a hyaluronic acid containing gauze pad in leg ulcers of venous or mixed aetiology.
abstract: OBJECTIVE
  To investigate the efficacy and safety of an hyaluronic acid (HA)-impregnated gauze pad compared with a hydrocolloid (HC) dressing, in patients with leg ulcer of venous or mixed aetiology.
  
  
  METHODS
  A 56-day blind-observer, randomised, multicentre, controlled, non-inferiority trial. Patients were randomised to receive either an HA gauze pad (ialuset gauze pad) or an HC dressing (DuoDERM E).The primary endpoint was the difference between the groups regarding the percentages of patients achieving a reduction of at least 40% of the initial wound surface after 56 days of treatment (visit 5). Secondary endpoints included reduction of wound area, aspect of the wound (percentage of necrotic,fibrinous or granulation tissue), rate of complete ulcer healing, pain intensity, and clinical status of the peri-ulcerous skin.
  
  
  RESULTS
  In total, 170 patients were included and analysed in the intention-to-treat (ITT) population; 27 patients presented at least one major protocol deviation and were excluded from the per-protocol (PP) population.Therefore, 143 patients constituted the PP population (n=72 and n=71 in the HA gauze pad group and HC dressing group, respectively).At day 56, the confidence interval of the difference between the two groups for the percentage of patients with a reduction of at least 40% of the target ulcer initial surface was [-0.128; 0.164] with a lower limit above the non-inferiority threshold (-0.15). Peri-ulcerous skin was significantly less impaired in the HA gauze pad group for oedema at day 56 (p = 0.04), purpura at day 14 (p = 0.009) and for maceration at day 14 (p = 0.003). Other secondary endpoints were not significantly different between the two groups. Overall, both treatments were well tolerated and adverse events were comparable between the two groups regarding their pattern, frequency, likely relationship to treatment and severity which was mostly mild (grade I) or moderate (grade 2). These results were confirmed in the overall ITT population.
  
  
  CONCLUSIONS
  These data support the non-inferiority of the HA gauze pad compared with HC for the primary endpoint.The significant differences in favour of HA gauze pad regarding peri-ulcerous skin changes (oedema, purpura and maceration) may suggest a trend for HA gauze pad to have a better acceptability than the reference HC dressing.
  
  
  BACKGROUND
  This study was sponsored by Laboratoires Genévrier. Authors received honoraria for their contributions to the study, but have no other conflicts of interests to declare.
authors: Department of Dermatology, Hospital Saint-Eloi, Montpellier, France. o-dereure@chu-montpellier.fr
authors: O
authors: O
authors: Dereure
authors: J
authors: J
authors: Mikosinki
authors: Z
authors: Z
authors: Zegota
authors: F A
authors: FA
authors: Allaert
mesh_terms: D000293:Adolescent; D047070:Bandages, Hydrocolloid; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D057194:Intention to Treat Analysis; D007871:Leg Ulcer / Q000628:therapy*; D008297:Male; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000628:therapy
chemical_list: D006820:Hyaluronic Acid