Burn Injuries Clinical Trial
Official title:
An Open, Randomized, Comparative, Multi-centre Investigation Evaluating the Efficacy and Tolerance of Mepilex Ag Versus Silver Sulfadiazine in the Treatment of Deep Partial Thickness Burn Injuries.
The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag) compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn injuries.284 in-patients in 8-12 centres in China will be evaluated. Treatment period will be up to 4 weeks with either Mepilex Ag or SSD.
Subjects enrolled in this investigation were in-patients at eleven centers in China. To be
included, subjects had to have deep partial-thickness burn injuries. The subjects were
consecutively allocated to a subject code providing they fulfilled all inclusion criteria and
none of the exclusion criteria and had signed a written informed consent form. Two evaluators
independent of each other made the judgment regarding depth of the burn before enrolling a
subject. The subjects were randomized to either receive Mepilex Ag or SSD.
Treatment period were up to four weeks with either SSD or Mepilex Ag. Changes of the
investigation products were performed according to a standardized schedule, unless the wound
healed before.
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