A Multicenter Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane dHACM in Decompressive Craniectomy Patients to Reduce Postoperative Scarring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Degree of scarring between the galea and the dura, as assessed by the Ease of Dissection (EOD) Score and histological analysis upon reoperation in patients receiving craniectomy with durotomy.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of dHACM in reducing scar tissue formation in craniectomy patients as well as facilitating reoperation and repair. Specifically this study compares craniectomy without dHACM application to craniectomy with placement of dHACM between the galea and dura over dural suture line and/or exposed parenchyma.
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
- Single (Participant)
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
- •Adults ages 18 or older.
- •Diagnosed with closed head trauma or cerebral infarction where decompressive craniectomy with durotomy is performed.
- •Willingness to comply with study procedures.
- •The patient's or legally authorized representative's (LAR's) ability to give full written consent.
排除标准
- •Prior surgery at the site
- •Participation in another ongoing trial
- •Open cranial wounds
- •Site exhibits clinical signs and symptoms of local infection.
- •Current diagnosis of cancer at the site
- •Prior radiation therapy treatment at the site.
- •Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
- •Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
- •Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
- •Currently taking medications which could affect graft incorporation (supervising physician's discretion).
- •Allergy to gentamicin sulfate and/or streptomycin sulfate
研究组 & 干预措施
Group 1 Control
Will receive only traditional craniectomy
干预措施: Craniectomy (Procedure)
Group 2 Treatment dHACM
Will receive craniectomy, but with the addition of a piece of dHACM placed over any dural defect or dural closure.
干预措施: dHACM (Other)
Group 2 Treatment dHACM
Will receive craniectomy, but with the addition of a piece of dHACM placed over any dural defect or dural closure.
干预措施: Craniectomy (Procedure)
结局指标
主要结局
Degree of scarring between the galea and the dura, as assessed by the Ease of Dissection (EOD) Score and histological analysis upon reoperation in patients receiving craniectomy with durotomy.
时间窗: 6 Months
次要结局
- Post-operative complications at original and re-operation(6 Months)
- Survival(6 Months)
- Intra- and post-operative complications at reoperation, as assessed by occurrence of violation of the dura and/or violation of the parenchyma.(6 Months)
- Peri-operative measures at original and re-operation(6 Months)