Efficacy and Safety of High Absorption Pad for Blood and Pus With Natural Antimicrobial Agent in Split-thickness Skin Graft Donor Site Wound
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- amounts of secondary gauze dressing
研究概览
简要总结
High absorption pad for blood and pus with natural antimicrobial agent or gauze dressing impregnated with paraffin, containing 0.5% chlorhexidine acetate (Bactigras) will be randomly covered on half of split-thickness skin graft donor site wound. The another will be cover on another half of split-thickness skin graft donor site wound. Then, they will be covered with gauzes and bandage. Time to wound healing, amounts of covered dressing gauzes, signs of infection, pain score, erythema index, melanin index, trans epidermal water loss index, and adverse events will be evaluated.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have split-thickness skin graft donor site wound on thigh
- •Age 18-60 years
- •Can read and write
- •Can follow the study protocol
- •Available on appointment date
排除标准
- •Systemic infection
- •Chronic skin diseases
- •Immune deficiency
- •Allergic to cellulose, chitosan, sericin, and chlorhexidine
- •Psychotic disorders
- •Pregnancy or breast feeding
结局指标
主要结局
amounts of secondary gauze dressing
时间窗: not more than 28 days
The amounts of secondary gauze dressing that will be changed because of blood over capacity.
wound healing time
时间窗: not more than 28 days
The day that the dressing will detach without painful.
次要结局
- signs of infection(not more than 28 days)
- transepidermal water loss index(3 months)
- alanine aminotransferase in serum(not more than 28 days)
- adverse events(not more than 28 days)
- aspartate aminotransferase in serum(not more than 28 days)
- serum creatinine(not more than 28 days)
- pain score(5 days after donor site wound was created)
- scar melanin index(3 months)
- scar erythema index(3 months)
- scar quality(3 months)
- blood urea nitrogen(not more than 28 days)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University