An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds
The overall objective of this post market clinical follow-up (PMCF) investigation is to confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds, with Mepilex Border Flex as the secondary dressing, when used in accordance with the Instructions for Use.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds
Center for Clinical Research
San Francisco, California, United States
Sycamore Wound Care and Hyperbaric Center
Miamisburg, Ohio, United States
evaluate the safety and performance of Exufiber Ag+ in medium to high exuding chronic wounds
open, non-comparative, multicenter investigation
Time frame: 28 Days
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