Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh---A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- wound infection rate
研究概览
简要总结
This study aims to compare the effectiveness of two wound dressings, Acticoat Absorbent (AA) and BCT Antimicrobial (BCT) on Split Thickness Skin Graft (STSG) donor site.
详细描述
Seventy patients who undergo STSG procedure in Kaohsiung Veterans General Hospital will be recruited. Two donor sites of equal lengths and widths on the same thigh, which are at least 2 cm apart will be covered randomly with AA and BCT each. Wound healing rate and infection rate will be assessed at 7 and 14 days after surgery. Degrees of pain and itchiness will be assessed daily with Visual Analogue Scale for the first 7 post-operative days. Scar appearance will be assessed with Vancouver Scar Scale 1, 3 and 6 months post-operatively.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who need STSG, longer than 8 cm and wider than 5 cm, from their thighs
排除标准
- •systemic steroid
- •old scar on thigh
- •systemic infection
- •anticipated use of antibiotics for more than 24 hours after operation
- •pregnancy
- •previous chemotherapy within 3 months before operation
- •anticipated chemotherapy within 3 months after operation
- •not over 20 years old
- •non-communicable
- •burn area more than 20% total body surface area
- •systemic auto-immune disease
- •liver cirrhosis
- •allergy to carbon fiber or alginate
- •anticipated MRI study
- •dry wound
研究组 & 干预措施
Acticoat Absorbent
Acticoat Absorbent wound dressing
干预措施: Acticoat Absorbent (Device)
BCT wound dressing
wound dressing
干预措施: BCT (Device)
结局指标
主要结局
wound infection rate
时间窗: 7 days
wound healing rate
时间窗: 14 days
percentage of wound area that has healed at this time
次要结局
- scar appearance(6 months)
- pain and itchiness(7 days)
研究者
Kuei-Chang Hsu
Consultant Surgeon
Kaohsiung Veterans General Hospital.