Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring
NCT ID: NCT02033824
Last Updated: 2018-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2014-04-30
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1 Control
Will receive only traditional craniectomy
Craniectomy
Removal of the skull flap followed by closure techniques per current SOC.
Group 2 Treatment dHACM
Will receive craniectomy, but with the addition of a piece of dHACM placed over any dural defect or dural closure.
dHACM
A piece of dHACM placed over any dural defect or dural closure during craniectomy.
Craniectomy
Removal of the skull flap followed by closure techniques per current SOC.
Interventions
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dHACM
A piece of dHACM placed over any dural defect or dural closure during craniectomy.
Craniectomy
Removal of the skull flap followed by closure techniques per current SOC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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MiMedx Group, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Chris Clare, MD
Role: PRINCIPAL_INVESTIGATOR
MiMedx Group, Inc.
Locations
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Boulder Neurological Associates
Boulder, Colorado, United States
Chattanooga Center for Neurological Research
Chattanooga, Tennessee, United States
Countries
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Other Identifiers
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AFCRAN001
Identifier Type: -
Identifier Source: org_study_id
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