Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 14
- 主要终点
- Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)
研究概览
简要总结
This is a randomized, within-subject controlled study to compare the clinical performance of the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1) confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, achieved for the ReCell-treated and control treatment areas. Safety will be evaluated in terms of long-term durability, scar outcomes and treatment-related adverse events.
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
- None
盲法说明
The participant and blinded evaluator will be not be told which treatment area received which treatment (RECELL or Control).
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject requires skin grafting as a result of an acute thermal burn injury (i.e. injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water).
- •The area of total burn injury is 5-50% TBSA inclusive.
- •Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints.
- •The subject is at least 5 years of age.
- •The subject (or family, for those under 18 years of age) is willing and able to complete all followup evaluations required by the study protocol.
- •The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
- •The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
- •The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.
排除标准
- •The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
- •The subject is unable to follow the protocol.
- •The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
- •The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
- •Life expectancy is less than 1 year.
结局指标
主要结局
Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)
时间窗: Prior to or at 8 weeks
Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for RECELL-treated areas as compared to control areas.
Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments)
时间窗: Prior to or at 8 weeks
For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas.
次要结局
- Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score(At 24 Week)
- Patient's Satisfaction/Treatment Preference(At 24 Week)
- Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score(Week 24)