Use of a new, flexible lipidocolloid dressing on acute and chronic wounds: results of a clinical study.

OBJECTIVE To document the performance (efficacy, tolerability and acceptability) of Urgotul Flex, a new, more flexible version of the lipidocolloid dressing Urgotul, in the management of acute and chronic wounds. Efficacy was defined as the reduction in ulcer surface area after 4 weeks of treatment. METHOD This open, non-comparative, multicentre clinical trial recruited patients from 11 centres, which included surgical, burns and rehabilitation units and paediatric, geriatric and dermatology wards. Inclusion criteria were non-infected wounds of any aetiology that were <120cm2 in size. Ulcer surface area was assessed by tracing and planimetry. Acceptability parameters were: ease of dressing application; pain at dressing change; dressing adherence to wound bed and bleeding at removal; maceration of surrounding skin; these were all assessed qualitatively. Patients were followed up for a maximum of 4 weeks, or until they healed if this occurred first. Efficacy and tolerability were assessed by the physicians on a weekly basis, and acceptability by the nursing staff at each dressing change. All of the physicians/nurses had previously participated in clinical evaluations of Urgotul using the same outcomes and assessments, and so performed a retrospective assessment of the two dressings. RESULTS Forty-four patients from 11 investigating centres were included in the study. The mean baseline surface area at was 21cm2 and 6cm2 for the acute and chronic wounds respectively. Twenty wounds (17 acute wounds and three chronic wounds) healed. Of the remainder, the mean surface area reduction was 78% and 42% for the acute and chronic wounds respectively at the end of the 4-week treatment period. Only two local adverse events were reported, but these were not considered to be dressing related. Based on the 345 documented dressing changes, conformability of the new dressing was considered to be superior to that of Urgotul, particularly when used on acute wounds. CONCLUSION These findings show that the efficacy and tolerability of Urgotul Flex is similar to that reported in previous observational studies on Urgotul. However, results show it is more flexible and thus more conformable, particularly when used on wounds in awkward locations, including paediatric wounds and hand surgery. CONFLICT OF INTEREST This evaluation was sponsored by Laboratoires URGO, Chenôve, France.