NCT03529578已完成不适用
A Case Series to Investigate the Safety and Efficacy of Weekly Application of Dehydrated Human Amnion/Chorion Membrane in the Treatment of Pressure Ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage of subjects with complete wound closure of study ulcer
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of dehydrated amnion/chorion membrane (dHACM) in the treatment of patients with stage II or III pressure ulcer and decubitus ulcers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Index ulcer characteristics:
- •Index ulcer area after debridement is ≥ 2 cm² and ≤ 25 cm² at the randomization visit
- •Ulcer must be Stage II or III as determined by the National Pressure Ulcer Advisory Panel (NPUAP) pressure ulcer staging system
- •Subject criteria must include:
- •Age 18 or older
- •The subject or their legally authorized representative provides consent and is willing and able to participate in all procedures and follow-up evaluations necessary to complete the study
排除标准
- •Index ulcer characteristics that will make subject ineligible for enrollment:
- •Stage I or IV ulcers as determined by NPUAP pressure ulcer staging system
- •Signs and symptoms of local infection
- •Previous surgical procedure performed at site
- •Known or suspected local skin malignancy at index ulcer site
- •Prior radiation therapy treatment at the index ulcer site
- •Subject criteria that will make subject ineligible for enrollment:
- •Presence of other diseases which, in the Opinion of the Investigator, may result in allograft failure or has experienced graft failure in the past (examples include: immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV)
- •Currently taking medications which in the opinion of the investigator may affect graft incorporation
- •Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
- •Any condition(s) that in the opinion of the investigator may seriously compromises the subject's ability to participate in this study. Examples include: known history of poor adherence with medical treatment, current drug or alcohol abuse or a medical/psychiatric condition
- •Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
- •Subjects currently enrolled in this study (i.e. concurrent enrollment in the study is prohibited)
- •Subject has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
- •Any pathology that would limit the blood supply and compromise healing
- •Subject is a prisoner
结局指标
主要结局
Percentage of subjects with complete wound closure of study ulcer
时间窗: 8 Weeks
The percentage of subjects with complete wound closure of the study ulcer
次要结局
- Wound healing kinetics: Complete wound healing(8 weeks)
- Wound healing kinetics: rate of closure/week(8 weeks)
- Wound healing kinetics: Weekly percentage of wounds with total closure(8 weeks)
- Incidence of Treatment-Emergent Adverse Events [Safety](8 weeks)
- Wound Infection Rate [Safety](8 weeks)
研究者
研究点 (2)
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