Arthroplasties, Knee Replacement Clinical Trial
Official title:
A Single Center, Open, Non-controlled Investigation to Evaluate the Performance of a Flexible, Self-adherent Absorbent Silver Dressing Coated With a Soft Silicone Layer After Elective Primary Total Hip or Knee Arthroplasty
The overall rationale for this investigation is to evaluate the clinical performance potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related post-operative wound complications such as blistering, maceration and redness at the incision and surrounding skin.
This was a descriptive, open, prospective, non-controlled clinical investigation conducted on
21 enrolled subjects at one site in the United states of America (USA).
The target subjects were male or female, 18 years and older, undergoing elective primary hip
or knee arthroplasty with a possibility to participate in a follow-up visit 7 days after
surgery. The primary purpose was to investigate if there was any skin damage under the
dressing from operation day to last visit. Performance of the dressing as well as comfort,
conformability, acceptability and pain at dressing removal was also followed-up until post-op
day 7.
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