A Phase 3 Multicenter, Single-Arm, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of StrataGraft® Construct in Pediatric Subjects With Deep Partial Thickness (DPT) Thermal Burns
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieved Confirmed Complete Closure of StrataGraft Treatment Sites Without Autograft Within 12 Weeks of StrataGraft Application
研究概览
简要总结
Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the participant's own body (donor site) to the burned part. Autografting is the usual treatment for DPT burns.
It works to close the wound, but can cause other problems:
- Donor sites are painful, can become infected or scarred, or can even become full thickness (FT) wounds themselves
- Treatment problems can require more grafting
- Additional surgery increases the risk of medical problems caused by the treatment
Stratatech is trying to find a safe and effective alternative to autografting to promote the healing of severe burns. The purpose of this study was to evaluate whether StrataGraft treatment eliminates or reduces the need for autografting and promotes wound closure in a pediatric population with thermal burns that contain intact dermal elements and for which autografting is clinically indicated (DPT burns).
Participants were enrolled into one of two age-based cohorts: 2 to < 12 years and 12 to ≤ 17 years to receive a single application of StrataGraft, in up to 3 non-contiguous DPT burn areas located on the same extremity or plane of the torso.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent provided by the parent(s) or legal guardian(s) and assent from the child when appropriate
- •Have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary
- •Thermal burns of no more than a total of 30% TBSA
- •Study treatment sites that are DPT in depth and which are clinically indicated for excision and autografting, and located on the torso or extremities
- •Study treatment area(s) totaling 0.5% to 10% TBSA and may be composed of up to 3 non-contiguous areas located on the same extremity or plane of the torso
- •Sufficient healthy skin available and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
排除标准
- •Is pregnant or breastfeeding
- •Receiving treatment to suppress the immune system and/or systemic corticosteroids (inhaled corticosteroids are permitted)
- •A known history of malignancy
- •Pre-admission insulin-dependent diabetes
- •Concurrent trauma, conditions, and/or personal situations that, in the opinion of the investigator, may compromise the participant's safety or the study objectives
- •A burn injury that occurred ≥ 14 days prior to planned StrataGraft application Is expected to survive less than 12 months
- •Is participating in another interventional trial, or did within 90 days before enrollment
- •A proposed study treatment site that has been previously excised or autografted; located adjacent to an undebrided/unexcised burn area; demonstrates signs and symptoms of wound infection, per judgement of the clinical investigator; lies across joints or is located on the feet (i.e., distal to the malleolus), hands (distal to the wrist), face, neck, buttocks, perineum, or genitalia
研究组 & 干预措施
2 to < 12 years Age Group Cohort
Single application of StrataGraft to 0.5% to 10% total body surface area (TBSA) on Day 1.
干预措施: StrataGraft (Biological)
12 to ≤ 17 years Age Group Cohort
Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.
干预措施: StrataGraft (Biological)
结局指标
主要结局
Percentage of Participants Who Achieved Confirmed Complete Closure of StrataGraft Treatment Sites Without Autograft Within 12 Weeks of StrataGraft Application
时间窗: Up to Week 12
Confirmed complete wound closure is defined as complete skin re-epithelialization confirmed at 2 consecutive visits at least 2 weeks apart, but no later than Week 20. Percentage of participants whose burn healed after StrataGraft treatment without needing the doctor to treat the burn with skin cut from other parts of the patient's own body were reported.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to Month 12
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant who is administered a study treatment, which does not necessarily have to have a causal relationship with this treatment. TEAEs are AEs with an onset date on or after the start of StrataGraft treatment.
次要结局
- Percentage of StrataGraft Treatment Sites Per Participant Closed at Week 12 Without Autograft Placement(At Week 12)
- Number of Confirmed Complete Wound Closures of the StrataGraft Treatment Sites on or Before Week 12 Without Autograft Placement(Up to Week 12)
- Mean of Averaged Percent Area of StrataGraft Treatment Sites Per Participant Autografted by Week 12(Up to Week 12)