A Prospective, Multicenter, Randomized, Controlled Clinical Investigation Evaluating the Safety and Efficacy of Dehydrated Human Amnion-Intermediate-Chorion Membrane (dHAICM) Allograft vs Standard of Care in the Treatment of Partial Thickness Thermal Burns
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 70
- 主要终点
- Time to Complete Epithelialization
研究概览
简要总结
This study will evaluate the efficacy of a dehydrated human placental tissue product, commercially labeled as AmCoreMatrix Burn ™ versus SOC in the closure of partial thickness burns. Human Cellular and Tissue based Products (HCT/Ps), specifically Dehydrated Human Amnion - Intermediate Layer - Chorion Membrane (dHAICM) offer a multimodal biological approach to burn management. Unlike synthetic dressings or silver-based creams, dHAICM serves as a sophisticated bioactive scaffold. It is a minimally manipulated allograft that provides superior tensile strength and barrier function compared to single-layer membranes. This study aims to document its performance in hospital burn units.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years of age or older
- •One or more thermal burns classified as either superficial partial thickness or deep partial thickness.
- •Total Body Surface Area (TBSA) involvement between 5% and 15%.
- •Total burn index wound area is greater than 25 cm 2 and less than 0.25 m 2 (2500 cm 2 )
- •1 If 2 or more burns are present, each must have an area greater than 15 cm 2
- •The participant must be willing and able to participate in the informed consent process.
排除标准
- •Full thickness burns.
- •Burns present for >72 hours prior to study evaluation
- •Burns requiring immediate autografting.
- •Superficial burns (1 st -degree) or burns not meeting criteria to be included in TBSA calculations.
- •Chemical or electrical burns.
- •Burns secondary to blast injury.
- •Burns causing vascular or respiratory compromise and burns requiring escharotomy
- •Any severe systemic comorbidities which could impair healing (e.g. active sepsis or major organ failure).
- •Known coagulopathy, platelet disorder, INR > 1.6, PTT > 38s, or platelets < 50,000 per mm 3
- •Uncontrolled diabetes.
- •Known life expectancy of < 6 months.
- •Evidence of active infection in burn.
- •Target area for treatment includes the head, neck, palms of hands, soles of the feet, or genitals.
- •Viral infection which could impair healing or immune function (e.g. HIV, HBV, HCV)
- •Participants of childbearing potential who are pregnant, considering becoming pregnant within the next 6 months, and/or are unwilling to utilize an appropriate form of contraception.
- •Currently requiring dialysis or planning to start within 6 months.
- •Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.
- •Treated with hyperbaric oxygen therapy or a skin substitute within the 30 days prior to screening visit.
- •Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.
- •Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
研究组 & 干预措施
AIC and Standard of Care
Participants with a thermal burn classified as either superficial partial thickness or deep partial thickness will receive treatment with an Amnion-Intermediate-Chorion (AIC) sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first.
干预措施: Standard of Care (SOC) (Procedure)
Standard of Care
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first.
干预措施: Standard of Care (SOC) (Procedure)
AIC and Standard of Care
Participants with a thermal burn classified as either superficial partial thickness or deep partial thickness will receive treatment with an Amnion-Intermediate-Chorion (AIC) sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first.
干预措施: Amnion-Intermediate-Chorion (Other)
结局指标
主要结局
Time to Complete Epithelialization
时间窗: 1-10 weeks
Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.
次要结局
- Percentage of Burn Area Change(1-10 weeks)
- Frequency of Full Epithelialization(1-10 weeks)
- Changes in Pain Scores Associated with Target Burns(1-10 weeks)
- Changes in Scarring Quality of Target Burn(1-10 weeks)
- Incidents of Adverse Events(1-10 weeks)