A Comparative Efficacy and Safety Study Between Two Silver Containing Dressings In Post-Op Wound Healing
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 device: BCT Silver Bandage
- Comparator device:"ConvaTec"Aquacel® Ag Hydrofiber Dressing
- 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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Comparative Efficacy and Safety Study Between BCT Silver Bandage and Aquacel® Ag. Dressing In Obstetrical and Gynecological Post-Op Wound Healing|
- Efficacy measurements [ Time Frame: 42 days after operation ] [ Designated as safety issue: No ]
- Wound infection rate within 5 days after operation
- Wound healing evaluation by Stony Brook Scar Evaluation Scale (SBSES), to be evaluated by blinded PI at V6
- Skin discoloration around the incision wound and/or wound keloid formation rate at V6
- Patient and Observer Scar Assessment Scale (POSAS) on V3, V5 and V6
- Safety Measurement [ Time Frame: 42 days after operation ] [ Designated as safety issue: Yes ]The incidence of postoperative skin reactions (defined as blisters, itching, erythematous change around the surgical wound site) within 5 days after operation
|Study Start Date:||June 2012|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
|Experimental: BCT Silver Bandage||
Device: BCT Silver Bandage
Activated carbon fiber impregnated with silver particles
|Active Comparator: Aquacel® Ag. Dressing||
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.
|Contact: Yu-Chih Chen, PhD||+886-4-23554588 ext firstname.lastname@example.org|
|Contact: Dai-Jen Lee, PhD||+886-4-23554588 ext email@example.com|
|Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital||Recruiting|
|Taichung City, Taiwan, 40201|
|Contact: Chih-Jen Tseng, MD + 886-4-24739595 ext 34501 firstname.lastname@example.org|
|Principal Investigator:||Chih-Jen Tseng, MD||Dep. of Gynecology and Obstetrics, Chung-Shan Medical University Hospital|