Evaluation of silver sulfadiazine 1%-cerium nitrate 2.2% cream efficacy and safety in moderate to severe burn patients: a single-blind randomized clinical trial.

IF 1.4 Q3 EMERGENCY MEDICINE International Journal of Burns and Trauma Pub Date : 2023-10-15 eCollection Date: 2023-01-01
Emad Molaei, Hedyieh Karbasforooshan, Ali Ahmadabadi, Mohammadreza Abbaspour, Seyed Hasan Tavoosi, Majid Khadem-Rezaeian, Ali Molaei, Sepideh Elyasi
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Abstract

Background: Burn injury is a major global health crisis. Topical antimicrobials such as silver sulfadiazine (SSD) are commonly used for superficial burn wounds. SSD has a broad-spectrum antimicrobial activity and also anti-inflammatory property, but also suffers from some limitations. Therefore, some studies suggest to add cerium nitrate (CN) to SSD, as an immunomodulatory and tanning agent with antitoxic properties, but its effect on patients' mortality, length of hospital stay, and bacterial colonization is contraversial.

Objectives: In this research, we evaluated the efficacy and safety of SSD 1%+CN 2.2% cream in patients with moderate to severe burn.

Material and methods: Twenty-two patients who fulfilled the inclusion criteria randomly were assigned to the intervention (n=7) or control (n=15) group and received SSD 1%+CN 2.2% or SSD cream 1% respectively, once daily until the complete re-epithelization or prepration of the burned skin for grafting. Intesity of pain, re-epithelialization time, required interventions, laboratory and clinical findings and final outcome were recorded.

Results: There was no significant difference in re-epithelialization time between the treatment and control groups (P>0.05). The same findings were reported about the required interventions and laboratory and clinical parameters. However, the final outcome and the pain score on third day were significantly better in the treatment group (P=0.017). On the other hand, all patients in the treatment group needed graft surgery.

Conclusion: Use of SSD 1%+CN 2.2% cream did not significantly improve re-epithelization time or infection occurrence and patients' pain, but also increased graft surgery rate in comparison with SDD 1% cream in moderate to severe burns.

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评价磺胺嘧啶银1%-硝酸铈2.2%乳膏对中重度烧伤患者的疗效和安全性:一项单盲随机临床试验。
背景:烧伤是一项重大的全球健康危机。局部抗菌剂,如磺胺嘧啶银(SSD)通常用于浅表烧伤。固态硬盘具有广谱抗菌和抗炎作用,但也有一定的局限性。因此,一些研究建议在SSD中添加硝酸铈(CN),作为一种具有抗毒性的免疫调节剂和晒黑剂,但其对患者死亡率、住院时间和细菌定植的影响存在争议。目的:在本研究中,我们评估SSD 1%+CN 2.2%乳膏对中重度烧伤患者的疗效和安全性。材料与方法:将符合纳入标准的22例患者随机分为干预组(n=7)和对照组(n=15),分别给予SSD 1%+CN 2.2%或SSD乳膏1%,每日1次,直至烧伤皮肤完全复上皮或准备植皮。记录疼痛强度、再上皮化时间、所需干预措施、实验室和临床结果以及最终结果。结果:治疗组与对照组再上皮化时间比较,差异无统计学意义(P>0.05)。关于所需的干预措施以及实验室和临床参数也报告了相同的结果。而治疗组的最终结局及第3天疼痛评分明显优于对照组(P=0.017)。另一方面,治疗组所有患者都需要移植手术。结论:在中重度烧伤患者中,与SDD 1%乳膏相比,使用SDD 1%+CN 2.2%乳膏对再上皮时间、感染发生率和患者疼痛无明显改善,但移植手术率增加。
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