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. RESEARCH DESIGN AND 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.
RCT Entities:
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. RESEARCH DESIGN AND 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.
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