Eberlein T, Haemmerle G, Signer M, Gruber Moesenbacher U, Traber J, Mittlboeck M, Abel M, Strohal R
Department of Surgery, Salmaniya Medical Centre, Arabian Gulf University, Manama, Bahrain.
J Wound Care. 2012 Jan;21(1):12, 14-6, 18-20. doi: 10.12968/jowc.2012.21.1.12.
This study compares treatment with a polihexanide-containing biocellulose wound dressing (BWD+PHMB) versus the best local standard of silver dressings (Ag) in painful, critically colonised (wounds-at-risk) or locally-infected wounds.
Patients with wounds of various aetiologies, a baseline VAS pain score >4 and a semi-quantitative bacterial load of ++ or higher were randomly allocated to receive treatment with either BWD+PHMB or Ag. Patients with systemic infections and/or using systemic antibiotics were excluded. The primary endpoint, patient-reported pain (VAS total pain, including the sub-scores pain at night, during the day, before, and 15min after dressing changes), was compared between treatment groups and scored on days 0, 1, 3, 7, 14, 21 and 28. Secondary outcomes of bacterial load, wound bed and periwound skin condition, quality of life and dressing handling were assessed at the same visits.
Thirty-eight patients (BWD+PHMB, n=21 [24 wounds]; Ag, n=17 [18 wounds]) were included in the analyses. Baseline variables showed no significant differences. Wound pain was reduced significantly in both groups, with a better pain reduction noted for BWD+ PHMB (p<0.001) before dressing changes. Compared with Ag, in the BWD+PHMB group critical colonisation and local wound infection had been reduced significantly faster and better (p<0.001) over the 28-day study period. Improved quality of life, good tolerability and no adverse events were demonstrated for both groups.
Both BWD+PHMB and AG were effective in reducing pain and bacterial burden. However, that BWD+PHMB was significantly faster and better in removing the critical bacterial load, makes this dressing an attractive therapeutic option to treat critically colonised and locally-infected wounds.
本研究比较含聚己缩胍的生物纤维素伤口敷料(BWD+PHMB)与银敷料(Ag)这一最佳局部标准治疗在疼痛、严重定植(有风险伤口)或局部感染伤口中的效果。
将各种病因导致的伤口、基线视觉模拟评分(VAS)疼痛评分>4且半定量细菌载量为++或更高的患者随机分配接受BWD+PHMB或Ag治疗。排除有全身感染和/或使用全身抗生素的患者。比较治疗组之间的主要终点,即患者报告的疼痛(VAS总疼痛,包括夜间、白天、换药前及换药后15分钟的疼痛子评分),并在第0、1、3、7、14、21和28天进行评分。在相同访视时评估细菌载量、伤口床和伤口周围皮肤状况、生活质量及敷料处理等次要结局。
38例患者(BWD+PHMB组,n=21[24处伤口];Ag组,n=17[18处伤口])纳入分析。基线变量无显著差异。两组伤口疼痛均显著减轻,换药前BWD+PHMB组疼痛减轻更明显(p<0.001)。与Ag组相比,在28天研究期内,BWD+PHMB组严重定植和局部伤口感染的减轻显著更快且更明显(p<0.001)。两组均显示生活质量改善、耐受性良好且无不良事件。
BWD+PHMB和Ag在减轻疼痛和细菌负荷方面均有效。然而,BWD+PHMB在清除严重细菌载量方面显著更快且更有效,使其成为治疗严重定植和局部感染伤口的有吸引力的治疗选择。