NCT01605968

A Comparative Efficacy and Safety Study Between Two Silver Containing Dressings In Post-Op Wound Healing

A Comparative Efficacy and Safety Study Between BCT Silver Bandage and Aquacel® Ag. Dressing In Obstetrical and Gynecological Post-Op Wound Healing

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Bio-medical Carbon Technology Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Wound

Interventions

Type	Name	Description
DEVICE	BCT Silver Bandage	Activated carbon fiber impregnated with silver particles
DEVICE	Aquacel® Ag. Dressing	Antimicrobial primary dressing incorporating the unique gelling action of Hydrofiber® Technology with ionic silver for wounds that are infected or at risk of infection.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-10-01
• Completion: 2014-01-01
• First posted: 2012-05-25
• Last updated: 2017-07-14

Locations

1 site across 1 country: Taiwan