NCT07326657Enrolling By Invitation4 期
Open-label, Controlled, Randomized, Multicenter Study Evaluating Intact Fish Skin Graft in Promoting AutoLOgous Skin Tissue ReGeneratIon of Deep Partial-Thickness Burns: The LOGI Study
干预措施
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- Kerecis Ltd.
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Difference in percentage area of the IFSG treatment site and control autograft treatment site that required autografting by 1 month.
研究概览
简要总结
The goal of this randomized controlled clinical trial is to determine whether use of Kericis Intact Fish Skin Graft (IFSG) can decrease the amount of autograft tissue needed for treatment of deep partial-thickness burns in patients at least 18 years of age with a deep partial-thickness burn for whom autograft treatment is clinically indicated. This clinical trial seeks to collect the following:
- Difference in the percentage area of the IFSG treatment site and control autograft treatment site that required autografting within 1 month of treatment
- Proportion of subjects achieving durable wound closure of the IFSG treatment site without autograft placement within 2 months of treatment
- Difference in cosmesis between the IFSG treatment site and autograft treatment site a year after treatment
- Difference in the pain intensity between the IFSG treatment site and autograft treatment site
Each participant will receive autograft and intact fish skin graft (IFSG) on different areas of their deep partial-thickness burn. Participants will be assessed for the need for further autograft treatment. Participants will also be assessed for wound closure, pain, and cosmesis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age at time of consent
- •Must have thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated.
- •Be able to provide written informed consent or have a legally authorized representative
- •Have sufficient healthy skin identified and designated as a potential donor site in the event that the IFSG treatment site requires autografting.
- •Investigator expects that the donor site will heal without grafting
- •Have a complex skin defect of 3 to 49% Total Body Surface Area, which can consist of more than one contiguous area
- •At the time of debridement:
- •Have thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated
- •Study treatment areas can be up to 2000 cm2
- •Must have at least 100 cm2 TBSA for which autografting is indicated and on which IFSG can be applied, which may be composed of up to 3 non-contiguous areas located on the same extremity or plane of the torso
- •Application of IFSG or SOC must be initiated within 14 days of injury (Application of IFSG or SOC must be initiated within 14 days of injury)
- •Have first excision and grafting of study treatment sites
- •Have thermal burn(s) on the torso or extremities
排除标准
- •Known allergy or hypersensitivity to fish (shellfish allergy is OK)
- •Female who is actively pregnant or currently breast-feeding
- •Vulnerable populations
- •Currently receiving systemic immunosuppressive therapy
- •Current or known history of malignancy or receipt of chemotherapy
- •History of Diabetes with documented uncontrolled diabetes (as defined by an A1C >9) within the last 6 months
- •Have an expected survival of less than 3 months
- •Are currently participating/have participated in the treatment group of an interventional study within 90 calendar days prior to consent
- •Have other wounds present for > 30 days
- •At the time of debridement:
- •Treatment area is assessed as full-thickness after debridement
- •Treatment areas on the face, neck, head, hands, feet, buttocks, perineum, and areas over joints (Treatment areas may only be on the torso or extremities)
- •Have a clinical or laboratory determination of infection at the anticipated treatment sites.
研究组 & 干预措施
IFSG-Treated Area of Burn
Experimental
The area of the deep partial-thickness burn that is treated with IFSG
干预措施: Intact fish skin graft (Device)
SOC Autograft-Treated Area of Burn
Active Comparator
The area of the deep partial-thickness burn that is treated with autograft as standard-of-care
干预措施: autograft (Procedure)
结局指标
主要结局
Difference in percentage area of the IFSG treatment site and control autograft treatment site that required autografting by 1 month.
时间窗: From initial surgical IFSG/autograft treatment post-enrollment to 28 +/- 3 days later
次要结局
- Proportion of subjects achieving durable wound closure of the intact fish skin treatment site at Month 2 without autograft placement(From initial treatment with IFSG/autograft post-enrollment to 60 +/- 7 days later)
- Difference in cosmesis between the IFSG treatment site and autograft treatment site at Month 12 based on observer POSAS total score(From initial treatment with IFSG/autograft post-enrollment to 365 +/- 30 days later)
- Difference in the pain intensity between the IFSG treatment site and autograft treatment site one week after treatment based on the Wong-Baker FACES pain rating scale (FPRS)(From initial treatment with IFSG/autograft post-enrollment to 7 +/- 1 days later)
研究者
研究点 (1)
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