Trial C, Darbas H, Lavigne J-P, Sotto A, Simoneau G, Tillet Y, Téot L
Bacteriology Laboratory, Arnaud de Villeneuve Hospital, Montpellier, France.
J Wound Care. 2010 Jan;19(1):20-6. doi: 10.12968/jowc.2010.19.1.46095.
To compare the efficacy and tolerability of a new ionic silver alginate matrix (Askina Calgitrol Ag) with that of a standard silver-free alginate dressing (Algosteril).
Patients with locally infected chronic wounds (pressure ulcers, venous or mixed aetiology leg ulcers, diabetic foot ulcers) or acute wounds were eligible for this prospective, open-label, controlled and randomised trial. Patients were randomised to receive one of the two dressings for a two-week period. Criteria of efficacy were based on the evolution, from day 1 to day 15, of local signs of infection using a clinical score ranging from 0 to 18, and the evolution of the bacteriological status for each wound. The latter was determined by (blind) bacteriological examinations of results obtained from two biopsies performed at days 1 and 15. A three-point scale (deterioration, unchanged, improvement) was also used. Acceptability, usefulness and tolerance were also assessed.
Forty-two patients (20 women and 22 men, 68.9 +/- 18.8 and 66.5 +/- 15.7 years old respectively) were randomly assigned to receive either Askina Calgitrol Ag (n=20) or Algosteril (n=22). Most had chronic wounds such as pressure ulcers (57%) or venous or mixed aetiology leg ulcers and diabetic foot ulcers (29%); few had acute wounds (14%). Clinical scores of infection were comparable in both groups at inclusion, 8.9 +/- 2.4 and 8.6 +/- 3.2 in the Askina Calgitrol Ag group and the Algosteril group respectively (not significant), but decreased significantly in both groups at day 15, 3.8 +/- 2.9 in the Askina Calgitrol Ag group (p=0.001) and 3.8 +/- 3.4 in the Algosteril group (p=0.007). There was no significant difference between the two groups at day 15. Although there was also no significant difference in bacteriological status between the treatment groups, a trend in favour of Askina Calgitrol Ag was found for the relative risk of improvement, especially in patients who were not treated with antibiotics either at the beginning of the study or during it. No differences between groups were observed regarding local tolerance, acceptability and usefulness of the dressings.
The regression of local signs of infection, local tolerance, acceptability and usefulness were similar for the two dressings. However, Askina Calgitrol Ag improved the bacteriological status of the wounds. Further trials are required to show that it has a positive impact on the healing process.
比较新型离子型海藻酸银基质（Askina Calgitrol Ag）与标准无银海藻酸盐敷料（Algosteril）的疗效和耐受性。
局部感染的慢性伤口（压疮、静脉或混合病因的腿部溃疡、糖尿病足溃疡）或急性伤口患者符合本前瞻性、开放标签、对照和随机试验的条件。患者被随机分配接受两种敷料之一，为期两周。疗效标准基于从第1天到第15天使用0至18的临床评分评估的局部感染体征的演变，以及每个伤口的细菌学状态的演变。后者通过对在第1天和第15天进行的两次活检结果进行（盲法）细菌学检查来确定。还使用了一个三点量表（恶化、不变、改善）。还评估了可接受性、有用性和耐受性。
42例患者（20名女性和22名男性，分别为68.9±18.8岁和66.5±15.7岁）被随机分配接受Askina Calgitrol Ag（n = 20）或Algosteril（n = 22）。大多数患者患有慢性伤口，如压疮（57%）或静脉或混合病因的腿部溃疡以及糖尿病足溃疡（29%）；少数患者患有急性伤口（14%）。纳入时两组的感染临床评分相当，Askina Calgitrol Ag组和Algosteril组分别为8.9±2.4和8.6±3.2（无显著性差异），但在第15天时两组均显著下降，Askina Calgitrol Ag组为3.8±2.9（p = 0.001），Algosteril组为3.8±3.4（p = 0.007）。在第15天时两组之间无显著差异。尽管治疗组之间的细菌学状态也无显著差异，但在改善的相对风险方面发现了有利于Askina Calgitrol Ag的趋势，尤其是在研究开始时或研究期间未接受抗生素治疗的患者中。在敷料的局部耐受性、可接受性和有用性方面未观察到组间差异。
两种敷料在局部感染体征的消退、局部耐受性、可接受性和有用性方面相似。然而，Askina Calgitrol Ag改善了伤口的细菌学状态。需要进一步的试验来证明其对愈合过程有积极影响。
