•
|
Sub-
|
•
|
Test materials compared to standards & competitor materials
|
•
|
Surface photography of implantation sites at regular intervals
|
•
|
Implant site assessed at various time points after implantation
|
•
|
Gross inspection & documentation (e.g. photography) of implant sites
|
•
|
Histological/biochemical assessment to determine bio-
|
•
|
Documentation of adverse/unexpected events through the study
|
•
|
Study period – up to a maximum of 12 months
|
v
|
extent & duration of the inflammatory response
|
v
|
extent & form of cellular ingress
|
v
|
extent of foreign body reaction development
|
v
|
extent of peri-
|
•
|
Widely used bio-
|
•
|
Valuable performance & safety data
|
•
|
Bio-
|
•
|
The impact of inadvertent entrapment of dressing materials in wounds
|