Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane dHACM in Decompressive Craniectomy Patients to Reduce Postoperative Scarring

Conditions
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Scarring

Intervention / Treatment
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* Other: dHACM
* Procedure: Craniectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1 Control<br>Will receive only traditional craniectomy | Procedure: Craniectomy<br>* Removal of the skull flap followed by closure techniques per current SOC.<br>* Other names: Decompressive Craniectomy;|
| Experimental: Group 2 Treatment dHACM<br>Will receive craniectomy, but with the addition of a piece of dHACM placed over any dural defect or dural closure. | Other: dHACM<br>* A piece of dHACM placed over any dural defect or dural closure during craniectomy.<br>* Other names: AmnioFix®;Procedure: Craniectomy<br>* Removal of the skull flap followed by closure techniques per current SOC.<br>* Other names: Decompressive Craniectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra- and post-operative complications at reoperation, as assessed by occurrence of violation of the dura and/or violation of the parenchyma. |  | 6 Months | 
| Post-operative complications at original and re-operation |  | 6 Months | 
| Peri-operative measures at original and re-operation |  | 6 Months | 
| Survival |  | 6 Months |