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. METHOD: 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 theHA 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. CONCLUSION: 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. DECLARATION OF INTEREST: 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.
RCT Entities:
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. METHOD: 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. CONCLUSION: 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. DECLARATION OF INTEREST: 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: José Verdú-Soriano; Marisol de Cristino-Espinar; Silvia Luna-Morales; Caridad Dios-Guerra; Javier Caballero-Villarraso; Paloma Moreno-Moreno; Antonio Casado-Díaz; Miriam Berenguer-Pérez; Ipek Guler-Caamaño; Olga Laosa-Zafra; Leocadio Rodríguez-Mañas; José Luis Lázaro-Martínez Journal: J Clin Med Date: 2022-02-25 Impact factor: 4.241
Authors: Gill Norman; Maggie J Westby; Amber D Rithalia; Nikki Stubbs; Marta O Soares; Jo C Dumville Journal: Cochrane Database Syst Rev Date: 2018-06-15