An Adaptive, Randomized, Controlled Trial Evaluating the Effectiveness of PermeaDerm® (PD) as Compared to Mepilex Ag® Used as Standard of Care in the Treatment of Adult and Pediatric Partial Thickness Burns.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Alternate therapy
研究概览
简要总结
A total of 68 adult and pediatric patients who suffer from at least one discrete partial thickness thermal burn wound (Grade II) will be recruited. Subjects will be randomized (1:1) to either PermeaDerm® or Mepilex Ag®. Evaluations will occur at 7, 14 and 21 days with long term follow-up at 6 and 12 months.
详细描述
A total of 68 adult and pediatric patients who suffer from at least one discrete partial thickness thermal burn wound (Grade II) will be recruited from the clinical practices of the site Principal Investigators.
Participants and/or the Legally Authorized Representative (LAR) as appropriate will be fully informed regarding the conduct of the clinical trial including all potential risks and benefits.
All Participants must be consented, randomized (1:1) and treated within 72 hours of injury.
It is permissible for a Study Participant to be enrolled if they have more than one burn wound.
If more than one partial thickness burn is treated, the Investigator must indicate prior to randomization which wound is to be considered for primary analysis. This wound will be called the Primary Wound and is to be evaluated by a Blinded Assessor.
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)
盲法说明
It is intended that blinded assessment of wounds will be performed at 14 days after treatment.
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be included if all the following criteria are met.
- •Able to give informed consent and undergo treatment < 72 hours of injury (consent may be given by LAR as necessary);
- •Any adult or pediatric patient < 75 years of age;
- •Target burn to be at least one discrete partial thickness (second degree) thermal burns <20% total body surface area (TBSA) on anybody surface except the face;
- •Characteristics of treated wound (s) must be superficial to deep partial thickness wounds such that application of both PermeaDerm and Mepilex Ag is medically appropriate;
- •Agrees to abstain from the use of any other wound covering device for the duration of the study unless determined by the individual site Principal Investigator to be medically necessary;
- •Demonstrates the ability and willingness to follow the requirements of the protocol.
排除标准
- •Participants will be excluded if s/he meet any of the following criteria.
- •Pregnant or breastfeeding;
- •Target burn ≥ 20% TBSA;
- •Electrical burns, chemical burns, frostbite;
- •Treatment with silver sulfadiazine prior to presentation;
- •Has comorbidities and/or medications and/or health status that (at the discretion of the individual site Principal Investigator) could result in poor wound healing (some examples may include admission to intensive care unit, inhalation, or other significant burn associated conditions, uncontrolled and/or significant diabetes, peripheral vascular disease, active malignancy, autoimmune disease, smoking, drug abuse, renal failure, steroid usage.
结局指标
主要结局
Alternate therapy
时间窗: 14 days
Time to conversion to alternate therapy- primary wound
Reepithelialization
时间窗: 14 days
Time to 100 percent- primary wound
次要结局
- Alternate therapy(up to 12 Months)
- Scar characteristics(6 and 12 months)
- Re-epithelialization(14 days)
- Adverse Events(21 days)
- Severity of pain(Up to 12 Months)
- Dressing Changes Required(Up to 21 Days)
- Satisfaction with treatment(6 and 12 months)