A Randomized Clinical Investigation to Evaluate the Efficacy of Cytal® Burn Matrix in the Management of Partial-Thickness Burns to the Hand
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Time to Complete Wound Healing
研究概览
简要总结
This is a randomized controlled trial (RCT) aimed at determining if use of Cytal® Burn Matrix in the management of partial-thickness burns to the hand shows improved wound healing times when compared to EZ-Derm Porcine Xenograft.
详细描述
A single site, two arm, parallel-design randomized trial comparing Cytal® Burn Matrix to EZ-Derm® Porcine Xenograft, for patients with partial-thickness burns to the hand. Up to 60 patients from a single center will be recruited and randomized (using a 1:1 randomization scheme) to receive either Cytal® Burn Matrix or EZ-Derm®. Scar formation, number of wounds requiring autografting, wound infections, rate of healing, hand function and impact of treatment will be compared between study arms. Additionally, a cost analysis and review of individual and group changes in narcotic prescription patterns and employment status will be evaluated. The protocol defined patient follow-up is 6 months.
An independent biostatistician will review all participant data for power and futility analysis. In addition, a clinical events committee will adjudicate adverse events (AEs) and serious adverse events (SAEs)
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female, 18 to 75 years of age.
- •Negative pregnancy test required.
- •Presence of partial thickness burns to one or both hands.
- •Thermal burn etiology.
排除标准
- •Allergy or hypersensitivity to materials in porcine-based study products or personal preference.
- •Friction, chemical, or electric burn etiology.
- •Immunosuppression.
- •Presence of a local and/or systemic infection.
- •Received prior treatment to the study site within 60 days of Screening.
- •Concurrent participation in another clinical trial.
结局指标
主要结局
Time to Complete Wound Healing
时间窗: 6 months
To Compare the time to complete wound healing between Groups 1 and 2
次要结局
- Rate of Healing(6 months)
- Evaluation of Scar Formation(6 months)
- Wound Infections(21 days)
- Compare treatment-emergent adverse event safety profile between Group 1 and Group 2(6 months)
- Wounds Requiring Autografting(6 months)
- Hand Function(6 months)
- Impact of Treatment(6 months)