A Phase III Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of StrataGraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 32
- 主要终点
- Percent Area of Treatment Sites Requiring Autografting by Month 3
研究概览
简要总结
About 70 participants will be enrolled. They will have complex skin defects because of burns caused by heat.
The burns will:
- be on 3-49% of the participant's total body surface area (TBSA)
- require surgery for skin replacement
- include intact dermal elements
The burns are called deep, partial-thickness thermal burns because the skin was damaged by heat but still has some dermis that was not damaged.
The dermis is the layer of skin under the outer layer (epidermis). It is the thickest layer of the skin that provides strength and flexibility to the skin.
All patients will receive both treatments, but on different areas of their burns. Their wounds will not be compared to other patients. One treatment area on their own body will be compared to the other one.
This will help to find out if StrataGraft is safe and effective for deep partial thickness burns. It will also see if StrataGraft might help healing enough to use it instead of the patient's own healthy skin to repair the damage.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject-specific criteria:
- •Men and women aged ≥ 18 years
- •Written informed consent
- •Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
- •Clinical expectation that the study donor site will heal without grafting
- •Complex skin defects of 3-49% TBSA
- •Total burn may consist of more than one area
- •Treatment site-specific criteria:
- •Thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated
- •Total of both study treatment areas can be up to 2000 cm2
- •First excision and grafting of study treatment sites
- •Thermal burn(s) on the torso, arms, or legs
排除标准
- •Subject-specific criteria:
- •Pregnant women
- •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 90 days prior to enrollment
- •Treatment site-specific criteria:
- •Full-thickness burns
- •Chronic wounds
- •The face, head, neck, hands, feet, buttocks, and area over joints
- •Treatment sites immediately adjacent to unexcised eschar
- •Clinical or laboratory determination of infection at the anticipated treatment sites
结局指标
主要结局
Percent Area of Treatment Sites Requiring Autografting by Month 3
时间窗: 3 Months
Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d).
Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3)
时间窗: Month 3
Wound closure of the treatment site was defined as complete skin re-epithelialization and the absence of drainage. A participant whose StrataGraft treatment site achieves durable wound closure without autograft placement is classified as a responder.
次要结局
- Pain at the Designated Donor Sites by Day 14(Day 3, Day 7 and Day 14, average of the 3 days reported)
- Total Scar Assessment (POSAS) Score by Observer at Month 3(at Month 3)