NCT02861560已完成不适用
A Case Series to Investigate the Safety and Efficacy of Weekly Application of Dehydrated Human Amnion/Chorion Membrane (dHACM) in the Treatment of Pressure Ulcers
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Healing Rate
研究概览
简要总结
A prospective case series investigating the efficacy and safety of dehydrated human amnion/chorion membrane (dHACM) in the treatment of patients with Stage II or III pressure 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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Index ulcer characteristics:
- •Ulcer present for ≥ 30 days (Day 0)
- •Index ulcer is located spine, lower back or buttocks
- •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 16 or older
- •The subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study (minors will provide assent with consent provided by parent)
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
研究组 & 干预措施
dHACM
Experimental
Dehydrated human amnion/chorion membrane (dHACM)
干预措施: dHACM (Other)
结局指标
主要结局
Healing Rate
时间窗: 8 weeks
次要结局
- Quality of Life(8 Weeks)
- Adverse Events(8 Weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A Single Center, Prospective, Case Series of the Treatment of Pressure Ulcers and Decubitus Ulcers.Pressure UlcerNCT03529578MiMedx Group, Inc.20
已完成
不适用
Use of Human Dehydrated Amnion Chorion Allograft in Closed HemorroidectomyExternal Hemorrhoid ThrombosedExternal HemorrhoidNCT03479489MiMedx Group, Inc.11
已完成
不适用
Use of dHACM in the Treatment of Venous Leg UlcersLeg UlcerNCT02011503MiMedx Group, Inc.128
终止
不适用
Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/PharyngectomyLarynx CancerPharynx CancerPharyngocutaneous FistulaNCT03479463MiMedx Group, Inc.8
已完成
不适用
Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone RegenerationRidge DeficiencyNCT03290638Samer Faraj43