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
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)
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)
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)