A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft 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
- 101
- 试验地点
- 24
- 主要终点
- Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority)
研究概览
简要总结
This is a randomized, within-patient controlled study to compare the clinical performance of the ReCell Device with that of Split-thickness Meshed Skin Grafts for the treatment of second degree burns. The hypothesis to be supported are: 1) non-inferiority with the primary efficacy endpoint defined as recipient site wound closure at week 4 follow-up visit of the ReCell-treated area as compared to that of the STMSG-treated area, and 2)superiority in the healing of the ReCell donor site as compared to the STMSG donor site at week 1.
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
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
- •The subject requires primary skin grafting as a result of an acute thermal burn injury
- •The area of the burn injury is at least 200cm2 (1% TBSA in adults) if a contiguous wound, or at least 100cm2 for each of 2 noon-contiguous wounds
- •The area of total burn injury is 1-20% TBSA
- •The burn injured area can be divided into two treatment areas ( control and treatment) with 100-320cm2 area for each treatment type
- •The study treatment area is a second degree burn injury
- •The subject is between 18-65 years of age
- •The subject is willing to complete all follow-up 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 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
- •The subject is able and willing to follow the protocol requirements
排除标准
- •The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances
- •The total subject burn injury is less than 1% or more than 20% TBSA
- •The subject has a microbiologically proven pre-existing local or systemic bacterial infection
- •The subject has been receiving a systemic antibiotic for more than 48 hours prior to grafting
- •The subject is known to have a pre-existing condition that may interfere with wound healing ( e.g. malignancy, diabetes, or autoimmune disease)
- •The subject is unable to follow the protocol
- •The subject is taking medication known to have an effect on wound healing or skin pigmentation ( e.g. systemic corticosteroids, retinoids, etc)
- •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
研究组 & 干预措施
all participants
All participants will receive both ReCell and split-thickness skin graft
干预措施: ReCell and Split-thickness skin graft (Device)
结局指标
主要结局
Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority)
时间窗: 4 weeks
Recipient site wound closure for both ReCell and STMSG will be defined as the presence of \>=95% epithelialization with contiguous layer of viable epithelium without the need for secondary surgical intervention. Factors considered during the assessment included color, presence of granulation tissue, and whether or not the entire wound is covered with a contiguous layer of viable epithelium. Using this definition, some small degree of punctate blistering was acceptable as long as the wound was \>=95% epithelialized.
Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority)
时间窗: 1 week
Donor site healing will be considered as complete (100%) wound closure if the following criteria were met: an ability to separate the dressing from the wound bed with visible presence over the entirety of the wound of dry, opalescent-pink external surface representing the newly formed outer cornfield layer of the epidermis.
次要结局
- Percent of Epithelialization at Each Visit Through Week 16(Each visit through Week 16)
- Wound Closure at Week 2 (Based on Investigators Assessment)(Week 2)
- Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment)(Pain (Weeks 1-16) and Appearance (Weeks 16-52))
- Mean Pain and Appearance Scores at Donor Sites (Subject Assessment)(Pain (Weeks 1-16) and Appearance (Weeks 16-52))