NCT03626701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 Standard of Care Dressings for Treatment of Partial-thickness Burns in Infants, Children and Adolescents (Aged 1-16 Years)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 18
- 主要终点
- Incidence of Index Burns With Day 10 Healing
研究概览
简要总结
A prospective, parallel-arm, randomized (1:1) multicenter trial to demonstrate that RECELL treatment of partial-thickness burn injuries, can safely and effectively increase the incidence of Day 10 healing compared with a standardized wound dressing.
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
- Single (Outcomes Assessor)
盲法说明
- Blinded Evaluator/Observer - local burn specialist
- Independent Reviewer
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 partial-thickness thermal burn injury.
- •The patient has a thermal burn injury that is:
- •≤ 30% TBSA (exclusive of superficial areas) and
- •≤ 10% of the burn injury TBSA is a full-thickness burn.
- •The Index Burn must be a clean partial-thickness burn injury > or = to 160 cm2 and between 2-20% BSA (inclusive).
- •The Index Burn may not cover the face, hand, foot or perineum/genitalia (Note: a patient with wounds in these areas may be enrolled but the Index Burn Area may not include these areas).
- •The patient and/or guardian agrees to comply with all compulsory study procedures and visit schedule.
- •The patient and/or parent/guardian agrees to abstain from any other treatment for closure of the Index Burn for the duration of the study, unless medically necessary.
- •The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
- •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,
- •Understand instruction, and
- •Provide voluntary informed written consent/assent as appropriate for study participation.
排除标准
- •Not able to understand English or Spanish.
- •Burns caused by chemicals, electricity or radiation.
- •Patients presenting with only 3rd-degree/full-thickness wounds which require immediate autografting.
- •Burn injury has had prior treatment for definitive closure.
- •Patients for whom use of sedation/general anesthesia is not medically appropriate.
- •Superficial/trivial burns or burns that in the investigator's opinion appear to be healing sufficiently such that care under this protocol would be inappropriate.
- •Patient requires immediate or staged surgical procedures for closure of their partial-thickness burns.
- •Conditions, e.g., previous burn injury to study area, poor nutritional status, poorly controlled diabetes mellitus (HbA1c >9%), that in the investigator's opinion may compromise subject safety or trial objectives.
- •Current use of medications, e.g., immunosuppressive agents (excluding inhaled corticosteroids), that in the investigator's opinion may compromise subject safety or trial objectives.
- •Inhalation injury.
- •Active infection, cellulitis or need for immediate grafting at the planned treatment areas.
- •Concerns for parent/guardian's ability to provide appropriate follow-up care.
- •Subjects with a known hypersensitivity to trypsin or compound sodium lactate for irrigation solution.
- •Subjects with a known sensitivity to silver.
- •In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
- •Immediate life-threatening condition or life expectancy less than one year.
- •Previous randomization within this investigation.
- •Post-Randomization Inclusion Criteria (prior to treatment):
- •Patient randomized (and will be treated) within 72 hours from the time of the burn injury.
- •Patient continues to meet all pre-randomization inclusion criteria.
- •Post-Randomization Exclusion Criteria (prior to treatment):
- •Incidental finding of any pre-randomization exclusion criteria.
- •Consented subjects who do not meet the post-randomization eligibility criteria and did not receive study treatment will be followed through the Day 28 visit and then withdrawn from the study. The criteria for which exclusion was based will be documented.
结局指标
主要结局
Incidence of Index Burns With Day 10 Healing
时间窗: 10 Days post-treatment
Day 10 healing will be evaluated by an observer blinded to treatment allocation with confirmation at Day 28
次要结局
- Incidence of Day 21 Healing of the Index Burn(Day 21, confirmed on Day 28)
- Incidence of Conventional Autografting to Achieve Healing of the Index Burn(Through Day 28)
研究者
研究点 (18)
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