Nasir Nur Azida Mohd, Saad Arman Zaharil Mat, Bachok Nor Sa'adah, Rashid Ahmad Hazri Ab, Ujang Zanariah, Noorsal Kartini, Yusof Norimah, Hashim Kamaruddin, Nor Fatimah Mohd, Imran Farrah-Hani, Yusof Nazri Mohd, Sharifudin Mohd Ariff, Halim Ahmad Sukari
Reconstructive Sciences Unit, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, Malaysia.
Reconstructive Sciences Department, Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia.
Indian J Plast Surg. 2022 Dec 22;56(1):44-52. doi: 10.1055/s-0042-1759503. eCollection 2023 Feb.
This clinical trial aimed to evaluate the clinical efficacy of chitosan derivative hydrogel paste (CDHP) as a wound bed preparation for wounds with cavities. This study enrolled 287 patients, with 143 patients randomized into the CDHP group (treatment) and 144 patients randomized into the commercial hydroactive gel (CHG) group (control). The granulation tissue, necrotic tissue, patient comfort, clinical signs, symptoms, and patient convenience during the application and removal of the dressing were assessed. The study was completed by 111 and 105 patients from the treatment and control groups, respectively. Both groups showed an increasing mean percentage of wound granulation over time when the initial wound size and comorbidity were adjusted (F(10,198) = 4.61; < 0.001), but no significant difference was found between the groups (F(1,207) = 0.043; = 0.953). The adjusted mean percentage of necrotic tissue of both groups showed a significant decrease over time (F(10,235) = 5.65; <0.001), but no significant differences were found between the groups (F (1,244) = 0.487; = 0.486). CDHP is equivalent to CHG and is an alternative in wound management and wound bed preparation for wounds with cavities.
这项临床试验旨在评估壳聚糖衍生物水凝胶糊剂（CDHP）作为有腔伤口创面准备的临床疗效。本研究纳入了287例患者，其中143例患者被随机分为CDHP组（治疗组），144例患者被随机分为商用水活性凝胶（CHG）组（对照组）。评估了肉芽组织、坏死组织、患者舒适度、临床体征、症状以及敷料应用和去除过程中的患者便利性。治疗组和对照组分别有111例和105例患者完成了研究。当对初始伤口大小和合并症进行调整后，两组的伤口肉芽平均百分比均随时间增加（F(10,198) = 4.61；P < 0.001），但两组之间未发现显著差异（F(1,207) = 0.043；P = 0.953）。两组坏死组织的调整后平均百分比均随时间显著降低（F(10,235) = 5.65；P < 0.001），但两组之间未发现显著差异（F(1,244) = 0.487；P = 0.486）。CDHP与CHG等效，是有腔伤口伤口管理和创面准备的一种替代方法。
