Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings in the Treatment of Partial Thickness Burns
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Wound healing
研究概览
简要总结
Burn injury is the result of an energy transfer that destroys the skin and adjacent tissues. Partial thickness burn wounds are painful and difficult to manage. The aim of burn treatment in partial thickness burns is to promote rapid wound healing, decrease pain, protect wound from infections, minimize scar formation and functional impairment In recent years, there are progressive development of new dressing material with a variety of option for depth adapted wound management. Many wound dressings are available for superficial and partial thickness burns. Hydrogel based wound dressing provides good biocompatibility with the skin and mucosa and promotes hydration of the wound bed.
Aluminaid wound dressings is a hydrogel based wound dressing that is integrated with aluminium that was designed to reduce acute pain in the treatment of superficial and partical thickness burn injuries.
Up to date, no evidence regarding integrated with aluminium sheet in hydrogel based wound dressings for the use in partial thickness burns. Therefore this trials is aimed to evaluate the efficacy and safety of Aluminaid versus Hydrogel for the treatment of partial thickness burns.
详细描述
This is a prospective, randomized, open label, active controlled trial that aim to evaluate the efficacy and safety of Aluminaid versus Hydrogel wound dressings in the treatment of partial thickness burns.
The study is a multi center trial in children and adults of 12 - 65 years old with partial thickness burns.
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 (Care Provider, Outcomes Assessor)
盲法说明
The person that assess the degree of epithelization will be presented with photos of the burn conditions and will not be given information of the patient's treatment.
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults and children of 12 - 65 years old
- •Partial thickness thermal burns of minimally 1% total body surface area (TBSA)
- •Admission of less than 4 hours of burn injury
- •Patients/legal guardian still have the ability to undergo examinations and give written informed consent.
排除标准
- •Total body surface area (TBSA) of more than 20%
- •Burns caused by chemicals, electricity or radiation
- •Superficial and partial thickness burns located on the faces, palms, soles, genitalia, perineum and joint areas
- •Superficial and partial thickness burns with compartment syndrome
- •Superficial and partial thickness burns with a history of life-threatening trauma
- •Had concomitant disease such as diabetes mellitus
- •Signs of infected burns
- •Patients with known allergies to product containing aluminium, hydrogel or a history of contact dermatitis
- •Other conditions which according to the investigator's judgment are not appropriate to be included in the study.
- •Treated with other agents before attend to clinic (oil, tooth paste, betadine, rivanol etc)
研究组 & 干预措施
Aluminaid
Treatment group: Aluminaid wound dressing
干预措施: Aluminaid (Device)
Hydrogel
Hydrogel wound dressing (Trademark: Burnshield)
干预措施: Hydrogel (Device)
结局指标
主要结局
Wound healing
时间窗: Up to 21 days
Wound healing as determine by the time of complete re-epithelization of the study area, in days.
次要结局
- Adverse events(At the time of admission up to 21 days of follow up)
- Erythema(at the time of admission up to 30 minutes)
- Pain score(At the time of admission up to 30 minutes and 1st week of follow up)
- Bullae(at the time of admission up to 30 minutes)
研究者
Melva Louisa
Trial Director
Indonesia University