A Prospective, Randomized Study to Evaluate the Effectiveness of Microsurfaced vs Control Cadaveric Decellularized Grafts to Establish Wound Bed Preparedness in Deep Partial and Full Thickness Burn Wounds
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Wound bed prep
研究概览
简要总结
This study is designed as a prospective, randomized, within subject controlled design to evaluate the effectiveness of Microsurfaced vs Control cadaveric grafts for coverage of acute deep-partial or full-thickness burn wounds to promote wound healing. This study will be performed in 2 parts: Time to wound bed preparedness through 6 weeks (Part A) and wound site healing, graft take and long-term scar outcomes (Part B). Subjects will be treated with both control and microsurfaced cadaveric grafts on adjacent deep-partial or full-thickness burn wounds.
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 (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent by patient or Legally Authorized Representative (LAR)
- •Subject with deep partial or full thickness burn injury due to flame burn, scald injury or contact burn
- •Study burn site large enough to accommodate placement of control and microsurfaced cadaveric graft (minimum 4 cm2 each) at the same location OR 2 study burn sites large enough to each accommodate control and microsurfaced cadaveric graft, respectively at minimum 4 cm
- •Total Body Surface Area burned (TBSA) total ≤30 %
- •Admission within 72 hours of burn injury
- •Non-infected wound as diagnosed by the attending physician upon admission
- •Treated as an outpatient or in an observational setting
- •21 years of age or older
排除标准
- •Burns involving the face
- •Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite)
- •Admission time greater than 72 hours after the injury
- •Wounds noted to be infected at admission
- •Is pregnant or plans to become pregnant
- •Is nursing or actively lactating
- •Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
- •Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's participation in the study protocol or record study materials
- •Any medical condition or co-morbidity that in the opinion of the investigator, would prevent successful participation in the study
结局指标
主要结局
Wound bed prep
时间窗: 6 week
To compare wound bed preparedness/time to autograft in deep-partial and full thickness burns and burn wound healing in partial thickness burns in burn sites treated with Microsurfaced vs Control cadaveric graft-treated groups through 6 weeks post initial injury.
次要结局
- Tissue oxygenation(3, 6, 9, 12 months)
- Infection(Through 12 months)
- Autograft take(2 weeks)
- Tissue Oxygenation(6 weeks)
- Scar assessment(3, 6, 9, 12 months)