Joachim Dissemond1, Michael Dietlein2, Ingo Neßeler3, Lutz Funke4, Oliver Scheuermann5, Elisa Becker6, Laetitia Thomassin7, Udo Möller6, Serge Bohbot7, Karl-Christian Münter8. 1. 1 Department of Dermatology, Venereology, and Allergology, University Hospital Essen, Essen, Germany. 2. 2 Medical Office Specialized on Diabetology, Stadtbergen, Germany. 3. 3 Medical Office Specialized on Vascular Medicine, Köln, Germany. 4. 4 Medical Office Specialized on Phlebology, Würzburg, Germany. 5. 5 Medical Office Specialized on Internal Medicine, Kornwestheim, Germany. 6. 6 URGO GmbH, Sulzbach, Germany. 7. 7 Medical Affairs Department, Laboratoires URGO Medical, Paris, France. 8. 8 Medical Office Specialized on Phlebology, Hamburg, Germany.
Abstract
OBJECTIVE: A description of wounds treated with a poly-absorbent silver dressing (with technology lipido-colloid with silver ions, TLC-Ag), and evaluation of the short-term clinical impact of the dressing on the wound healing process, under real-life conditions. METHOD: A large, prospective, multicentre, observational study of patients in 81 centres in Germany, presenting with an exuding wound at risk or with clinical signs of local infection for whom the evaluated TLC-Ag dressing (UrgoClean Ag, Laboratoires Urgo, France) has been prescribed. Main outcomes included: reduction in number of wound infections diagnosed and clinical signs of local infection, wound healing rate, clinical assessment of wound healing progression, relative wound area reduction (RWAR), local tolerability, handling and acceptance of the dressing. RESULTS: A total of 2270 patients with acute and chronic wounds of various aetiologies were treated with the evaluated dressing for a mean duration of 22±13 days. All clinical signs of local infection and the diagnosed wound infections were substantially reduced at two weeks after the treatment initiation. All wound infection parameters continued to reduce until the last visit. In the meantime, clinical improvement in wound healing was reported in 98.9% of acute wounds, with a wound closure rate of 68.5%. In chronic wounds, a median RWAR of 57.4% was achieved, with an improvement in healing process documented by clinicians in 90.6% of cases, stabilisation in 6.1% and worsening in 3.2%. Similar results were reported, regardless of exudate level and proportion of sloughy and granulation tissues in the wound bed at baseline. The dressing was well tolerated and well accepted by both patients and health professionals. CONCLUSION: These results, documented in a large cohort of patients treated in current practice, support and complete the clinical evidence on the healing properties and safety profile of the TLC-Ag dressing in the management of wounds at risk or with clinical signs of local infection, regardless of wound and patient characteristics. Declaration of interest: This study was supported by a grant from Laboratoires Urgo. UM, EB, LT and SB are employees of Laboratoires Urgo. JD, KCM and MD provided advisory and speaking services to pharmaceutical and other healthcare organisations including, but not limited to, Laboratoires Urgo. Data management and statistical analyses were conducted independently by INPADS GmbH, Germany.
OBJECTIVE: A description of wounds treated with a poly-absorbent silver dressing (with technology lipido-colloid with silver ions, TLC-Ag), and evaluation of the short-term clinical impact of the dressing on the wound healing process, under real-life conditions. METHOD: A large, prospective, multicentre, observational study of patients in 81 centres in Germany, presenting with an exuding wound at risk or with clinical signs of local infection for whom the evaluated TLC-Ag dressing (UrgoClean Ag, Laboratoires Urgo, France) has been prescribed. Main outcomes included: reduction in number of wound infections diagnosed and clinical signs of local infection, wound healing rate, clinical assessment of wound healing progression, relative wound area reduction (RWAR), local tolerability, handling and acceptance of the dressing. RESULTS: A total of 2270 patients with acute and chronic wounds of various aetiologies were treated with the evaluated dressing for a mean duration of 22±13 days. All clinical signs of local infection and the diagnosed wound infections were substantially reduced at two weeks after the treatment initiation. All wound infection parameters continued to reduce until the last visit. In the meantime, clinical improvement in wound healing was reported in 98.9% of acute wounds, with a wound closure rate of 68.5%. In chronic wounds, a median RWAR of 57.4% was achieved, with an improvement in healing process documented by clinicians in 90.6% of cases, stabilisation in 6.1% and worsening in 3.2%. Similar results were reported, regardless of exudate level and proportion of sloughy and granulation tissues in the wound bed at baseline. The dressing was well tolerated and well accepted by both patients and health professionals. CONCLUSION: These results, documented in a large cohort of patients treated in current practice, support and complete the clinical evidence on the healing properties and safety profile of the TLC-Ag dressing in the management of wounds at risk or with clinical signs of local infection, regardless of wound and patient characteristics. Declaration of interest: This study was supported by a grant from Laboratoires Urgo. UM, EB, LT and SB are employees of Laboratoires Urgo. JD, KCM and MD provided advisory and speaking services to pharmaceutical and other healthcare organisations including, but not limited to, Laboratoires Urgo. Data management and statistical analyses were conducted independently by INPADS GmbH, Germany.