Department of Orthopedic Surgery, Far Eastern Memorial Hospital, No. 21, Sec. 2, Nanya S. Rd, New Taipei City, 220, Taiwan (R.O.C.).
Department of Materials and Textiles, Asia Eastern University of Science and Technology, No.58, Sec.2, Sihchuan Rd, New Taipei City, 220, Taiwan (R.O.C.).
BMC Musculoskelet Disord. 2024 Jan 2;25(1):23. doi: 10.1186/s12891-023-07138-7.
Stable upper limb fractures, such as radius, ulna, or distal humerus fractures, are common pediatric orthopedic traumas that are traditionally managed with cast immobilization. The commonly used synthetic fiberglass cast is light and water resistant but may promote skin itchiness during casting, which is a common complaint of patients. In addition, these diisocyanate-based casts have been proven to be toxic and may cause asthma. Herein, we introduce a novel biobased polyester cast to compare its clinical outcomes and patient satisfaction with conventional synthetic fiberglass casts.
From Feb 2022 to Nov 2022, we undertook a single-center prospective randomized trial involving 100 children with cast-immobilized stable upper limb fractures. These patients were randomized into either biobased polyester or synthetic fiberglass groups. All patients were regularly followed up till the cast removal which occurred approximately 3-4 weeks after immobilizing. Objective clinical findings and subjective patient questionnaire were all collected and analyzed.
According to the radiographs taken on the day of cast removal, there was no loss of reduction in both groups. The incidence of skin problems was 3.4 times higher in the synthetic fiberglass group than in the biobased polyester group. For the subjective questionnaire, the biobased polyester cast was preferred in every sub-item.
Our study strongly suggested that the novel biobased polyester cast provides matching stability to conventional fiberglass casts and improves patient satisfaction in an eco-friendlier and safer way.
ClinicalTrials.gov Protocol Registration and Results System ( https://www.
gov/ ; ID: NCT06102603; Date: 26/10/2023).
稳定的上肢骨折,如桡骨、尺骨或肱骨远端骨折,是常见的儿科骨科创伤,传统上采用石膏固定治疗。常用的合成玻璃纤维石膏轻巧且防水,但在打石膏时可能会引起皮肤瘙痒,这是患者常见的抱怨。此外,这些基于二异氰酸酯的石膏已被证明具有毒性,并可能导致哮喘。在此,我们介绍一种新型的生物基聚酯石膏,以比较其与传统合成玻璃纤维石膏的临床效果和患者满意度。
我们于 2022 年 2 月至 2022 年 11 月进行了一项单中心前瞻性随机试验,纳入了 100 例采用石膏固定治疗稳定上肢骨折的儿童患者。这些患者被随机分为生物基聚酯组或合成玻璃纤维组。所有患者均定期随访至固定 3-4 周后拆除石膏。收集并分析了客观临床发现和主观患者问卷调查结果。
根据拆除石膏当天的 X 光片,两组均无复位丢失。合成玻璃纤维组皮肤问题的发生率比生物基聚酯组高 3.4 倍。对于主观问卷,生物基聚酯石膏在每个子项目中都更受青睐。
我们的研究强烈表明,新型生物基聚酯石膏在提供与传统玻璃纤维石膏相当的稳定性的同时,以更环保和更安全的方式提高了患者满意度。
ClinicalTrials.gov 协议注册和结果系统(https://www.clinicaltrials.gov/;ID:NCT06102603;日期:2023 年 10 月 26 日)。