聚氨酯泡沫敷料临床研究的思考

The Reflection on the Clinical Studies of Polyurethane Foam Dressing

聚氨酯泡沫敷料类产品的临床研究存在一定困难,本文归纳和分析了聚氨酯泡沫敷料临床研究中的基本要求和常见问题,以期为申报企业和临床研究人员在开展该类产品临床研究和撰写申报注册资料临床部分提供参考。

There are some difficulties in the clinical studies of polyurethane foam dressing.This article summarizes and analyzes the basic requirements and commonproblems of polyurethane foam dressing clinical studies from the perspective of technical review,in order to provide reference for manufacturers andinvestigators in the design of clinical studies and preparing the clinical part of registration documents.