Open-label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Single or Multiple Applications of StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 8
- 主要终点
- Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months
研究概览
简要总结
About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body.
This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss.
Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.
详细描述
The objective of this range-finding study was to assess the safety, tolerability, and efficacy of single or repeated application of StrataGraft skin tissue in full-thickness complex skin defects resulting from acute traumatic skin loss (eg, thermal burns or degloving injuries) requiring surgical excision and autografting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-65 years, inclusive
- •Written informed consent
- •Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
- •Complex skin defects of up to 49% Total Body Surface Area (TBSA) requiring excision and autografting
- •Total skin defect may consist of more than one wound area
- •Full-thickness complex skin defects requiring excision and autografting
- •Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400 cm2 in cohort 2
- •For thermal burns only, first excision and grafting of treatment sites
排除标准
- •Pregnant women and prisoners
- •Subjects receiving systemic immunosuppressive therapy
- •Subjects with a known history of malignancy
- •Preadmission insulin-dependent diabetic subjects
- •Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives
- •Expected survival of less than three months
- •Participation in the treatment group of an interventional study within the 90 days prior to enrollment
- •Chronic wounds
- •The face, head, neck, hands, feet, buttocks, perineum, and area over joints
- •Treatment sites with exposed tendon or bony prominences
- •Chemical and electrical burns
- •Treatment sites adjacent to unexcised eschar
- •Clinical suspicion of infection at the anticipated treatment sites
结局指标
主要结局
Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months
时间窗: 3 months
The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.
Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months
时间窗: 3 months
Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage
次要结局
- Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months(within 3 months)
- Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28(at days 3, 7, 14, 21, and 28)
- Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months(within 3, 6 and 12 months)
- Cosmesis of Treatment Sites at 3, 6, and 12 Months(within 3, 6, and 12 Months)
- Percent Wound Closure at 3, 6, and 12 Months(within 3, 6, and 12 Months)
- Cosmesis of Donor Sites at 3, 6, and 12 Months(within 3, 6, and 12 Months)