[Point on consideration of the clinical trial design and evaluation on the dressing applied to burn wound].
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.
Center For Medical Device Evaluation, SFDA, Beijing, 100044, China. yangxd@cmde.org.cn
Xiaodong
X
Yang
D001458:Bandages; D002056:Burns / Q000601:surgery*; D002986:Clinical Trials as Topic; D004867:Equipment Design; D006801:Humans; D008422:Materials Testing; D012107:Research Design; D014945:Wound Healing