Sterility and bioactivity evaluation of two types of bone graft substitutes after removing the original packaging.

Mehdi Ekhlasmand Kermani, Aida Kheiri, Reza Amid, Maryam Torshabi, Behzad Houshmand, Sepideh Parsayan
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Abstract

Background: Xenograft and allograft bone substitutes are widely used to replace the missing bone in defects. Since removing the packaging of these grafts can nullify their sterilization, this study aimed to evaluate the sterility and bioactivity changes of an allograft and a xenograft following uncapping/recap.

Methods: Two types of commercial allograft and xenograft vials were unpacked and further exposed to operating room air, where implant surgery was performed for one second, ten minutes, and one hour. After three repetitions, samples were analyzed using microbiological tests and scanning electron microscopy (SEM) with energy dispersive x-ray analysis (EDX) for sterility and bioactivity evaluation.

Results: None of the bone graft samples showed microbial growth or bioactivity-negative changes after seven days of unpacking the vials.

Conclusion: Despite the positive results of this study, future studies and more analysis considering influential factors are required. Also, disinfection and air exchange must still be observed during biomaterial application and bone grafting procedures.

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两种骨移植替代物去除原包装后的无菌性和生物活性评价。
背景:异种和同种异体骨替代物被广泛用于骨缺损的替代。由于去除这些移植物的包装会使其灭菌失效,因此本研究旨在评估打开/盖住后同种异体移植物和异种移植物的无菌性和生物活性变化。方法:打开两种类型的同种异体和异种移植小瓶,并进一步暴露于手术室空气中,在那里进行种植手术1秒,10分钟和1小时。重复三次后,采用微生物学试验和扫描电子显微镜(SEM)和能量色散x射线分析(EDX)对样品进行无菌性和生物活性评价。结果:开封7天后,所有骨移植样品均未出现微生物生长或生物活性阴性变化。结论:尽管本研究取得了积极的结果,但仍需要进一步的研究和更多的影响因素分析。此外,在应用生物材料和植骨过程中,仍然必须观察消毒和空气交换。
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CiteScore
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审稿时长
20 weeks
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