NCT03624192终止不适用
A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RES (Regenerative Epidermal Suspension) Prepared With the RECELL® Device Compared to Conventional Care for Healing of Donor Sites in Infants, Children and Adolescents (Aged 1-16 Years)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 7
- 主要终点
- Time to Complete Closure
研究概览
简要总结
To evaluate whether the time to complete closure is superior for RECELL-treated split-thickness donor sites, compared with Control (standardized dressings only). The mean time for donor site healing will be compared between treatments.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 1 through 16 years (inclusive) with a skin defect for which autografting is indicated.
- •The area of total injury or planned defect (excluding donor sites) is 5% to 25% Total Body Surface Area (TBSA), inclusive.
- •Two discrete donor sites of similar size (± 25%) can be created in a similar non-articulating location (excluding the scalp) with each donor site representing a minimum of 1% TBSA.
- •The patient and family member/parent/guardian are able to complete all follow-up evaluations required by the study protocol.
- •In the opinion of the Investigator, the patient and/or parent/guardian must be able to:
- •Understand the full nature and purpose of the study, including possible risks and adverse events, and
- •Provide informed consent/assent as appropriate for study participation.
- •The patient and/or parent/guardian agrees to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary and comply with all compulsory study procedures.
- •The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
- •The patient and/or parent/guardian can read and understand instructions and give informed, voluntary, written consent.
- •Life expectancy greater than 52 weeks.
排除标准
- •Prior autograft harvest at planned study donor sites.
- •Patients with sepsis or hemodynamic instability.
- •The patient has an infection under active management or other dermatologic condition at the planned donor sites or treatment areas.
- •Patient (of reasonable age) or parent/guardian is unable to follow the protocol requirements.
- •The patient has other concurrent conditions that in the opinion of the Investigator may compromise patient safety or study objectives.
- •Patients with a known hypersensitivity to trypsin or compound sodium lactate for irrigation.
- •In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
- •Enrollment in a concurrent study in which the study treatment may confound the endpoints of this study.
研究组 & 干预措施
RECELL® Autologous Cell Harvesting Device
Experimental
RECELL + Telfa™ Clear and Xeroform™ dressings
干预措施: RECELL® Autologous Cell Harvesting Device (Device)
Telfa™ Clear and Xeroform™ dressings
Active Comparator
Telfa™ Clear and Xeroform™ dressings
干预措施: Telfa™ Clear and Xeroform™ dressings (Other)
结局指标
主要结局
Time to Complete Closure
时间窗: up to 4 weeks
The primary effectiveness endpoint is time, in days, to complete closure (≥95% epithelialization by blinded assessor) of study donor sites confirmed at two consecutive visits.
次要结局
- Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment(Day 7 or 8)
- Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment(Day 7)
- Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)(Week 24)
- Donor Site Treatment Preference (Site A or Site B) Reported by Subject(4 weeks)
- Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)(Week 24)
- Donor Site Treatment Preference (Site A or Site B) Reported by Physician(4 weeks)
研究者
研究点 (7)
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