A novel non-invasive treatment in deep burned patients who do not have consent to surgery

Q3 Medicine
Seyed Hassan Tavoosi , Ali Ahmadabadi , Omid Yazarlou , Hossain Safari , Mahdi Kouhi Noghondar , Elaheh Emadi , Daryoush Hamidi Alamdari
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引用次数: 0

Abstract

One of the common traumatic injuries is burns. In deep burns, the standard of care (SOC) is surgical excision and skin grafting, still, some patients do not have consent to do the surgical procedure because of operation fear, comorbidity disorder, or contraindications for anesthesia. This study applied a novel repairing gel, also called SUPRAZ, to treat patients with deep burns to achieve outcomes similar to those of SOC. This gel was made from approved biochemical components involved in wound healing mechanisms. Over 18 months, from 2022 to 2024, this controlled single-arm clinical trial including 22 patients aged 4–80 years with deep partial or/and full thickness burns covering 0.5–12 % of their total body surface area was conducted. Despite the emphasis on surgery, these patients did not consent to do surgery. Therefore, repairing gel was applied topically on the burn area. Repairing gel time to heal the area of burns was 24.9 ± 8.5 (mean ± SD; days). The pain subsided after 10–15 min of use. During the 3–12 months follow-up of the patients, there were no signs of hypertrophic scars and keloids. The repairing gel was safe and can be used for patients who do not consent to surgery. Multicenter clinical trials are needed to substantiate the efficacy of repairing gel and achieving comparable long-term results to SOC in deep-burned patients. Trial registration: IRCT20191228045924N6.
一种新颖的非侵入性治疗深度烧伤患者谁不同意手术
最常见的创伤之一是烧伤。对于深度烧伤,标准的治疗方法是手术切除和植皮,但仍有部分患者因手术恐惧、合并症或麻醉禁忌症而不同意手术。本研究应用一种新型修复凝胶SUPRAZ治疗深度烧伤患者,达到与SOC相似的效果。这种凝胶是由经批准的参与伤口愈合机制的生化成分制成的。从2022年到2024年,这项为期18个月的对照单臂临床试验包括22名年龄4-80岁的患者,他们的深度部分或/和全层烧伤覆盖了他们体表面积的0.5 - 12%。尽管强调手术,但这些患者不同意做手术。因此,将修复凝胶局部涂抹在烧伤部位。修复凝胶时间为24.9±8.5(平均±SD;天)。使用10-15 min后疼痛消退。在3-12个月的随访中,患者没有出现增生性疤痕和瘢痕疙瘩的迹象。该修复凝胶是安全的,可用于不同意手术的患者。需要多中心临床试验来证实修复凝胶的有效性,并在深度烧伤患者中获得与SOC相当的长期效果。试验注册:IRCT20191228045924N6。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
1.20
自引率
0.00%
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0
审稿时长
15 weeks
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