Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT01605968
Brief Summary:
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.
Study:
NCT01605968
Study Brief:
Protocol Section:
NCT01605968