A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of the RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 35
- 主要终点
- Incidence of Treatment Area Healing
研究概览
简要总结
A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
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
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 patient requires autografting for treatment of an acute full-thickness skin defect (e.g., trauma- or surgery-related).
- •The maximum area requiring autografting is 50% Total Body Surface Area (TBSA).
- •Two comparable areas requiring autografting, each at least 160 cm2 (or 320 cm2 contiguous), excluding face and genitalia. When hands or joints are included in the treatment areas, comparability of treatment areas means that each area (RECELL and Control) must include the same contralateral joint and/or hand.
- •The patient is at least 5 years of age.
- •The patient (or parent/guardian) is willing and able to comply with all compulsory study procedures and visit schedule.
- •The patient agrees to abstain from any other treatment (e.g., external fixation) of the study treatment areas for the duration of his/her participation the study (1 year).
- •The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation the study (1 year).
- •In the opinion of the investigator, the patient and/or guardian must be able to:
- •Understand the full nature and purpose of the study, including possible risks and adverse events,
- •Understand instructions, and
- •Provide voluntary informed written consent.
排除标准
- •Not able to understand English or Spanish.
- •The area requiring autografting sustained a burn injury.
- •The treatment area has previously failed to heal subsequent to surgical intervention for closure.
- •The patient is unable to follow the protocol requirements.
- •The patient has a condition that in the investigator's opinion may compromise patient safety or trial objectives.
- •Current use of medications that in the investigator's opinion may compromise patient safety or trial objectives.
- •The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
- •The patient is pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
- •Life expectancy is less than 1 year.
结局指标
主要结局
Incidence of Treatment Area Healing
时间窗: Prior to or at 8 weeks
The incidence of healing is hypothesized to be non-inferior for RECELL-treated areas (Investigational Intervention) as compared to Control areas (Control Intervention). Healing is defined as complete wound closure characterized by 100% skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a Blinded Evaluator.
Donor Skin Area to Treatment Area Expansion Ratio
时间窗: Treatment Day
The donor skin expansion achieved with treatment using RECELL and widely meshed autograft (Investigational Intervention) is hypothesized to be superior to the donor skin expansion ratio achieved with conventional autograft treatment (Control Intervention). Expansion ratio, computed as the ratio of measured treated area to the measured donor site area, is calculated separately for each Intervention (including any donor skin needed for repeat treatments).
次要结局
未报告次要终点