刘贻声 1张广湘 1黄炜瑜 1梁锦源 1卢忠 2孔繁圃3
作者信息
- 1. 威科检测集团有限公司
- 2. 中国药品监督管理研究会医疗器械监管研究专业委员会
- 3. 清华大学医学院
- 折叠
摘要
Abstract
As an important class of implantable medical devices,absorbable surgical sutures play a critical role in clinical wound closure and tissue repair.Their safety,effectiveness,and degradation characteristics directly affect clinical therapeutic outcomes and patient prognosis.With the continuous development of novel absorbable materials such as poly(p-dioxanone)(PPDO)and poly(lactic-co-glycolic acid)(PLGA),alongside innovative products including barbed sutures and looped sutures,new requirements and challenges have emerged for preclinical evaluation.Based on current regulations,standards,and review practices,including the Guidelines for the Registration Review of Absorbable Surgical Sutures(2024 Revision),this paper systematically discusses the key technical considerations for preclinical large animal studies and in vivo degradation evaluation of absorbable surgical sutures.Particular attention is given to critical aspects of in vivo degradation studies,covering animal model selection,implantation methods,study time-point design,dynamic monitoring of physical and mechanical properties,and histopathological evaluation.Key elements of studies,such as model screening,suture site design,biomechanical analysis,and safety assessment,are also discussed.In addition,common issues identified during registration review are analyzed,including the selection of observation time points,image documentation,data integrity,and traceability.Finally,future trends are explored,including the establishment of in vitro-in vivo degradation correlations,evaluation methodologies for novel suture products,and the application of intelligent assessment technologies.This article aims to provide references for the design of preclinical large animal studies,in vivo degradation evaluation,registration submissions,and technical review of absorbable surgical sutures.关键词
可吸收外科缝线/临床前评价/大动物试验/体内降解/巴马小型猪/生物力学Key words
absorbable surgical sutures/preclinical evaluation/large animal studies/in vivo degradation/Bama miniature pigs/biomechanics分类
医药卫生
