Knee Injuries Clinical Trial
Official title:
A Prospective, Randomized, Controlled Clinical Investigation, Comparing Two Postoperative Wound Dressings Used After Elective Hip and Knee Replacement
The primary objective of this investigation is to evaluate if complications related to
surgical wound are more common in the treatment group compared to the control group starting
from operation day until last visit.
The secondary objectives are to evaluate:
- the performance of the dressing
- the comfort, conformability and the acceptability of the dressing
- pain before and during dressing removal on the last visit
A prospective, randomized clinical investigation will be conducted at two to three sites in
Belgium and Sweden.
Male or female, 18 years and older undergoing primary hip or knee arthroplasty with an
expected hospital stay of 4 days or longer will be included in to the clinical investigation.
100 evaluable patients (i.e. 50 subjects per arm). The treatment arm (either Mepilex Border
Post-Op or Aquacel Surgical) Patient eligibility will be established before treatment
randomization. Patients will be randomized using optimal allocation (minimization) balancing
for the following baseline variables type of surgery (hip or knee), age and skin status.
Eligible patients will be randomized to receive Mepilex Border Post-Op or Aquacel surgical in
a ratio of 1:1 provided.
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