Evaluation of Safety of Xeno-Skin™ for Treatment of Severe and Extensive, Partial and Full Thickness Burns
赞助:
XenoTherapeutics, Inc.
合作者:
信息的提供 (责任方):
，
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | November 2018 | ||
| 预计主要完成日期 | April 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Safety and Tolerability: Number of Participants with Adverse Events as a Measure of Safety and Tolerability[ Time Frame: 6 months ] Number of Participants with Adverse Events as a Measure of Safety and Tolerability Clinically Relevant Response[ Time Frame: daily through 4 weeks, 6 months ] To assess the quality and duration of temporary barrier function afforded by Xeno-Skin™(as determined by the Clinical Wound Assessment Scale, Scale 0-5 for 6 independent parameters for wound assessment Branski et al 2011) Time of Graft Adherence.[ Time Frame: daily through 4 weeks ] To assess the duration of temporary barrier function afforded by Xeno-Skin™ |
||
| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
|
||
| 描述性信息 | |||
| 简略标题 ICMJE | Evaluation of Safety of Xeno-Skin™ for Treatment of Severe and Extensive, Partial and Full Thickness Burns | ||
| 正式标题 ICMJE | An Open-label Phase 1 Study to Evaluate the Safety and Tolerability of Xeno-Skin™ for Temporary Coverage of Severe and Extensive, Deep Partial and Full Thickness Burn Wounds | ||
| 简要概况 | To assess the Safety and Tolerability of Xeno-Skin™ for the treatment of severe and extensive, deep partial and full thickness burn wounds as a first-line treatment, and temporary coverage prior to definitive wound closure. |
||
| 详细说明 | This Phase 1 Study is a 2 cohort, open-label, non-randomized trial, to assess the safety and tolerability of Xeno-Skin™ for the treatment of severe and extensive, deep partial and full thickness burn wounds as a first-line treatment, and temporary coverage prior to definitive wound closure. Subjects who meet eligibility criteria and provide informed consent will receive placement of Xeno-Skin™ on a single burn wound site. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 1 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
||
| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
|
||
| 研究工具 |
|
||
| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
6 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | July 2019 | ||
| 预计主要完成日期 | April 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. The subject or, when applicable, the subject's legally authorized representative, provides written informed consent to participate in this study 2. Age greater than 18 years old 3. Male or female of non-childbearing potential. Females must be: a. Naturally postmenopausal defined as ≥1 year without menses and: i. ≥55 years, or ii. <55 years with follicle-stimulating hormone (FSH) ≥40.0 IU/L; or iii. Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal ligation. 4. Total Burn Surface Area (TBSA) <30% to include deep partial thickness or full thickness burn wound 5. Burn injury requiring excision 6. Burn injury requiring temporary allograft coverage of wound based on clinical judgement prior to definitive wound closure with autologous skin grafts 7. Sufficient area of burn wound for Xeno-Skin™ placement, not previously treated with allograft, and not located on face or hands. Exclusion Criteria: 1. Pregnant or lactating women 2. Documented history of infection with human immunodeficiency virus (HIV) or other condition(s) that in the opinion of the Investigator may compromise patient safety or study objectives. 3. Immunosuppressive medication regimens e.g. antineoplastics, high dose steroids (> 10 mg prednisone/day), TNF alpha inhibitors, calcineurin inhibitors (cyclosporine, tacrolimus), antiproliferative agents, and other immunomodulators 4. Known allergy to penicillin, aminoglycosides (such as streptomycin) or amphotericin B. 5. Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in the past 5 years. Non-metastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ are allowed 6. Use of any experimental or investigational drugs within 30 days prior to placement of Xeno-Skin™ 7. Previously received a porcine or other xenogeneic tissue product, including but not limited to: glutaraldehyde fixed porcine or bovine bioprosthetic heart valve replacements and glutaraldehyde fixed porcine dermal matrix 8. BMI > 40 kg/m2 9. HbA1c ≥ 7.0% 10. Treatment with systemic corticosteroids within 30 days before screening (not including inhaled steroids) 11. Electrical or chemical burns 12. History of chronic end stage renal disease defined as an MDRD CrCl < 15 mL/min, or receiving chronic dialysis 13. History of chronic liver disease or cirrhosis (Child-Pugh Score C). Evidence of acute or chronic hepatitis B infection based on documented HBV serology testing 14. Known documented history of Hepatitis B, Hepatitis C, Treponema pallidum, Cytomegalovirus, herpes or varicella zoster Note: Successfully treated hepatitis C patients without evidence of end stage liver disease is allowed. If HCV antibody reactive, then HCV RNA must be undetectable. 15. Recent (within 3 months prior to study enrollment) MI, unstable angina leading to hospitalization, uncontrolled, CABG, PCI, carotid surgery or stenting, cerebrovascular accident, transient ischemic attack, endovascular procedure or surgical intervention for peripheral vascular disease or plans to undergo a major surgical or interventional procedure (e.g., PCI, CABG, carotid or peripheral revascularization) 16. Presence of venous or arterial vascular disorder directly affecting the area of burn wound 17. Pre-existing haemolytic anemia 18. Chronic malnourishment as determined by Investigator 19. Significant pulmonary compromise 20. Systemic anticoagulation at the time of treatment or INR > 2 21. Documented evidence of wound infection prior to treatment 22. Evidence of sepsis and/or end organ damage 23. Acute lung injury 24. Life expectancy of less than 180 days | ||
| 性别 |
|
||
| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
||
| IPD 共享声明 |
|
||
| 责任方 | ， | ||
| 研究赞助商 ICMJE | XenoTherapeutics, Inc. | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
|
||
| PRS 账户 | |||
| 验证日期 | October 2018 | ||
|
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
|||
请使用微信扫码报名
京公网安备 11010102003638号