Dissemond Joachim, Dietlein Michael, Neßeler Ingo, Funke Lutz, Scheuermann Oliver, Becker Elisa, Thomassin Laetitia, Möller Udo, Bohbot Serge, Münter Karl-Christian
1 Department of Dermatology, Venereology, and Allergology, University Hospital Essen, Essen, Germany.
2 Medical Office Specialized on Diabetology, Stadtbergen, Germany.
J Wound Care. 2020 Mar 2;29(3):162-173. doi: 10.12968/jowc.2020.29.3.162.
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.
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.
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.
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.
描述使用一种多吸收性银敷料（含脂质体 - 胶体银离子技术，TLC - Ag）治疗的伤口，并在实际生活条件下评估该敷料对伤口愈合过程的短期临床影响。
在德国81个中心对患者进行一项大型、前瞻性、多中心观察性研究，这些患者有渗出性伤口且有感染风险或有局部感染的临床体征，已开具评估的TLC - Ag敷料（UrgoClean Ag，法国Urgo实验室）。主要结果包括：诊断出的伤口感染数量减少、局部感染的临床体征、伤口愈合率、伤口愈合进展的临床评估、相对伤口面积减少（RWAR）、局部耐受性、敷料的操作便利性及接受度。
共有2270例患有各种病因急性和慢性伤口的患者接受了评估敷料治疗，平均治疗时间为22±13天。治疗开始两周后，所有局部感染的临床体征和诊断出的伤口感染均大幅减少。所有伤口感染参数在最后一次随访前持续降低。同时，98.9%的急性伤口报告有伤口愈合的临床改善，伤口闭合率为68.5%。在慢性伤口中，RWAR中位数达到57.4%，90.6%的病例临床医生记录到愈合过程有所改善，6.1%稳定，3.2%恶化。无论基线时伤口渗出水平以及伤口床中腐肉和肉芽组织的比例如何，均报告了类似结果。该敷料在患者和医护人员中耐受性良好且接受度高。
这些在当前临床实践中大量患者身上记录的结果，支持并完善了关于TLC - Ag敷料在治疗有感染风险或有局部感染临床体征伤口时的愈合特性和安全性的临床证据，无论伤口和患者特征如何。利益声明：本研究由法国Urgo实验室的资助支持。UM、EB、LT和SB是法国Urgo实验室的员工。JD、KCM和MD为制药及其他医疗保健组织（包括但不限于法国Urgo实验室）提供咨询和演讲服务。数据管理和统计分析由德国INPADS GmbH独立进行。
