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A randomized, controlled, double‐blind prospective trial with a L ipido‐ C olloid T echnology‐ N ano‐ O ligo S accharide F actor wound dressing in the local management of venous leg ulcers
Author(s) -
Meaume Sylvie,
Truchetet François,
Cambazard Frédéric,
Lok Catherine,
Debure Clélia,
Dalac Sophie,
Lazareth Isabelle,
Sigal MichèleLéa,
Sauvadet Anne,
Bohbot Serge,
Dompmartin Anne
Publication year - 2012
Publication title -
wound repair and regeneration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.847
H-Index - 109
eISSN - 1524-475X
pISSN - 1067-1927
DOI - 10.1111/j.1524-475x.2012.00797.x
Subject(s) - medicine , randomized controlled trial , confidence interval
Venous leg ulcers ( VLU s) are the most prevalent chronic wounds in western countries with a heavy socioeconomic impact. Compression therapy is the etiologic treatment of VLU but until now no wound dressing has been shown to be more effective than another. The aim of this study was to assess the efficacy of a new dressing in the management of VLU . Adult patients presenting a noninfected VLU and receiving effective compression therapy were enrolled in this randomized, controlled, double‐blind trial. The VLU s were assessed every 2 weeks for 8 weeks. The primary study outcome was the relative W ound A rea R eduction ( WAR , in %), and the secondary objectives were absolute WAR , healing rate, and percentage of wounds with >40% surface area reduction. One hundred eighty‐seven patients were randomly allocated to treatment groups. Median WAR was 58.3% in the L ipido‐ C olloid T echnology‐ N ano‐ O ligo S accharide F actor ( TLC‐NOSF ) dressing group (test group) and 31.6% in the TLC dressing group (control group) (difference: −26.7%; 95% confidence interval: −38.3 to −15.1%; p = 0.002). All other efficacy outcomes were also significant in favor of the TLC‐NOSF dressing group. Clinical outcomes for patients treated with the new dressing are superior to those patients treated with the TLC dressing (without NOSF compound), suggesting a strong promotion of the VLU healing process.