A Comparative Efficacy and Safety Study Between BCT Silver Bandage and Aquacel® Ag. Dressing In Obstetrical and Gynecological Post-Op Wound Healing
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Efficacy measurements
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Male/Female of any race aged between 18 - 70 years old
- •The subject is willing and able to understand, sign and date the study Informed Consent, and be able to adhere to the scheduled visits regimen.
- •The subject is having surgery (Cesarean pfannenstiel or Open Laparotomy incision) within 1 week
排除标准
- •Patients with known allergy or topical hypersensitivity to ionic silver or alginate
- •Any systemic or local active dermatological disease that might interfere with the evaluation of the surgical site such as eczema, psoriasis, skin cancer, scleroderma, chronic urticarial
- •Patients undergoing MRI (Magnetic Resonance Imaging) examination.
- •Subject residence is outside the study center city
- •Patients was participating in another clinical trial less than 30 days before participation in this trial
研究组 & 干预措施
BCT Silver Bandage
干预措施: BCT Silver Bandage (Device)
Aquacel® Ag. Dressing
干预措施: Aquacel® Ag. Dressing (Device)
结局指标
主要结局
Efficacy measurements
时间窗: 42 days after operation
1. Wound infection rate within 5 days after operation 2. Wound healing evaluation by Stony Brook Scar Evaluation Scale (SBSES), to be evaluated by blinded PI at V6 3. Skin discoloration around the incision wound and/or wound keloid formation rate at V6 4. Patient and Observer Scar Assessment Scale (POSAS) on V3, V5 and V6
次要结局
- Safety Measurement(42 days after operation)
