Mo Xiaohui, Cen John, Gibson Elaine, Wang Robin, Percival Steven L
Foshan United Medical Technologies Ltd, Guangdong, China.
Aspen Medical Europe Ltd, Redditch, United Kingdom.
Wound Repair Regen. 2015 Jul-Aug;23(4):518-24. doi: 10.1111/wrr.12298. Epub 2015 Jun 24.
Chitosan, a natural polysaccharide derivate from chitin, offers a promising alternative biomaterial for use in wound dressings. In this work, the safety and efficacy of a next-generation KA01 chitosan wound dressing in facilitating the healing of nonhealing chronic wounds was studied. This open multicenter comparative prospective randomized clinical study was conducted at three medical centers in China. A total of 90 patients (45 in test group and 45 in control group) with unhealed chronic wounds including pressure ulcers, vascular ulcers, diabetic foot ulcers, and wounds with minor infections, or at risk of infection, were treated with the next generation chitosan wound dressing as the test article or traditional vaseline gauze as a control. Baseline assessments were undertaken with the primary end point being wound area reduction. The secondary end points included pain reduction (using the NRS11 pain scale) at dressing change, wound exudate levels, wound depth and duration of the treatment. After 4 weeks treatment, the wound area reduction was significantly greater in the test group (65.97 ± 4.48%) than the control group (39.95 ± 4.48%). The average pain level in the test group was 1.12 ± 0.23 and 2.30 ± 0.23 in the control group. The wound depth was also lower in the test group 0.30 ± 0.48 cm than the control group 0.54 ± 0.86 cm. The level of exudate fell and the dressing could be removed integrally in both the test and control groups. The mean duration of the test group was 27.31 ± 5.37 days and control group 27.09 ± 6.44 days. No adverse events were reported in either group. In conclusion this open multicenter comparative prospective randomized clinical study has provided compelling evidence that the next generation chitosan wound dressing can enhance wound progression towards healing by facilitating wound reepithelialization and reducing the patients pain level. Furthermore the dressing was shown to be clinically safe and effective in the management of chronic wounds.
壳聚糖是一种从几丁质衍生而来的天然多糖，为伤口敷料提供了一种很有前景的替代生物材料。在这项研究中，研究了新一代KA01壳聚糖伤口敷料在促进不愈合慢性伤口愈合方面的安全性和有效性。这项开放性多中心比较性前瞻性随机临床研究在中国的三个医疗中心进行。共有90例慢性伤口未愈合的患者（试验组45例，对照组45例），包括压疮、血管性溃疡、糖尿病足溃疡以及有轻微感染或有感染风险的伤口，分别使用新一代壳聚糖伤口敷料作为试验用品或传统凡士林纱布作为对照进行治疗。进行基线评估，主要终点是伤口面积缩小。次要终点包括换药时的疼痛减轻（使用NRS11疼痛量表）、伤口渗出液水平、伤口深度和治疗持续时间。治疗4周后，试验组的伤口面积缩小（65.97±4.48%）明显大于对照组（39.95±4.48%）。试验组的平均疼痛水平为1.12±0.23，对照组为2.30±0.23。试验组的伤口深度也低于对照组，分别为0.30±0.48厘米和0.54±0.86厘米。试验组和对照组的渗出液水平均下降，且敷料均可完整去除。试验组的平均持续时间为27.31±5.37天，对照组为27.09±6.44天。两组均未报告不良事件。总之，这项开放性多中心比较性前瞻性随机临床研究提供了有力证据，表明新一代壳聚糖伤口敷料可通过促进伤口再上皮化和降低患者疼痛水平来促进伤口愈合进程。此外，该敷料在慢性伤口管理中显示出临床安全性和有效性。
