Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Time to complete healing
研究概览
简要总结
To examine the efficacy and safety of sericin dressing with collagen in STSG donor site treatment comparing with Bactigras®. Around 30 patients will be enrolled in this study.
详细描述
Wounds are a public health problem found worldwide that associated with both clinical and economic burdens. Although several wound dressings are available, some limitations of those dressings still existed resulting in the need for new wound dressing development.
The sericin dressing with collagen was developed to provide a moist environment and bioactive ingredients to the wound bed. To evaluate its efficacy and safety, the STSG donor sites of each patient will be divided into two equal areas. Each area will be randomly allocated into sericin dressing with collagen group or control group (Bactigras®). The outcomes will be collected to examine the efficacy and safety of sericin dressing with collagen in comparison with commercial dressing Bactigras®.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have STSG donor site wounds on the thigh area
- •Age more than 18 years old
- •The split-thickness skin graft is harvested for the first time at the investigated area.
- •Patients who are able to communicate with the Thai language
- •Willingness to participate
排除标准
- •Patient with a mental disorder or immunocompromised diseases
- •Patients who cannot or not willing to follow the protocol
- •Known sensitivity or allergy to sericin, chlorhexidine, and collagen
- •Pregnancy or lactation
结局指标
主要结局
Time to complete healing
时间窗: 42 days
The number of days since starting treatment until the primary dressing can spontaneously detach from wound with full re-epithelialization (at least 95% re-epithelialization) without any drainage.
次要结局
- Incidence of infection(42 days)
- Incidence of adverse effect(42 days)
- Pain score(42 days)
- Vancouver scar scale (VSS)(6 months)
- Patient scale of Patient and observer scar scale (POSAS)(6 months)
- Melanin level(6 months)
- Trans-epidermal water loss (TEWL)(6 months)
- Skin hydration(6 months)
- Erythema level(6 months)
- Skin elasticity(6 months)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University