Point on consideration of the clinical trial design and evaluation on the dressing applied to burn wound.
- Author:
Xiaodong YANG
1
Author Information
1. Center For Medical Device Evaluation, SFDA, Beijing, 100044, China. yangxd@cmde.org.cn
- Publication Type:Journal Article
- MeSH:
Bandages;
Burns;
surgery;
Clinical Trials as Topic;
Equipment Design;
Humans;
Materials Testing;
Research Design;
Wound Healing
- From:
Chinese Journal of Medical Instrumentation
2012;36(3):202-205
- CountryChina
- Language:Chinese
-
Abstract:
The relevant keypoints needed to be considered in clinical trials of dressing applied to burn wound when claiming for registration is discussed combining with the characteristics of burn wound and the dressing applied to wound surface in order to provide reference for development & clinical evaluation of dressing.