Surgical Wound Clinical Trial
Official title:
A Comparative Efficacy and Safety Study Between BCT Silver Bandage and Aquacel® Ag. Dressing In Obstetrical and Gynecological Post-Op Wound Healing
Study objective:
The objective of this study is to evaluate through clinical criteria the clinical efficacy
and safety of BCT Silver Bandage role in obstetrical and gynecological wound healing is as
effective and safe as Aquacel® Ag. Dressing.
Study devices:
- Study device: BCT Silver Bandage
- Comparator device:"ConvaTec"Aquacel® Ag Hydrofiber Dressing
Study design:
- Randomized, Open-label, interventional, comparative, preventive study with Blinded
evaluator.
- All subjects must meet all the inclusion & exclusion criteria to enter this study in
pre-operative phase.
- Eligible subjects will be enrolled after a scheduled operative procedure.
- There is SEVEN visits in this study (one screening eligibility phase up to 7 days before
OP day, and four post-op treatment scheduled visits consisting on 1st , 3rd day, 5th
day, 12th day and two follow up visit on the 28th and the 42nd post-operative day.
- During each scheduled visit, each subject will have colored picture of his wound after
dressing been removed, and on visit V6 for wound evaluation by blinded PI.
Number of subjects: It is expected to recruit ≧150 eligible subjects.
Study Duration: About eighteen month.
n/a
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