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Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring

Sponsor
MiMedx Group, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02033824
Collaborator
(none)
7
Enrollment
2
Locations
2
Arms
50
Duration (Months)
3.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: dHACM
  • Procedure: Craniectomy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Multicenter Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane dHACM in Decompressive Craniectomy Patients to Reduce Postoperative Scarring
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: Group 1 Control

Will receive only traditional craniectomy

Procedure: Craniectomy
Removal of the skull flap followed by closure techniques per current SOC.
Other Names:
  • Decompressive Craniectomy

    		•
    Experimental: Group 2 Treatment dHACM

    Will receive craniectomy, but with the addition of a piece of dHACM placed over any dural defect or dural closure.

    Other: dHACM
    A piece of dHACM placed over any dural defect or dural closure during craniectomy.
    Other Names:
  • AmnioFix®

    • Procedure: Craniectomy
    Removal of the skull flap followed by closure techniques per current SOC.
    Other Names:
  • Decompressive Craniectomy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Intra- and post-operative complications at reoperation, as assessed by occurrence of violation of the dura and/or violation of the parenchyma. [6 Months]

    2. Post-operative complications at original and re-operation [6 Months]

    3. Peri-operative measures at original and re-operation [6 Months]

    4. Survival [6 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boulder Neurological Associates Boulder Colorado United States 80303
    2 Chattanooga Center for Neurological Research Chattanooga Tennessee United States 37403

    Sponsors and Collaborators

    • MiMedx Group, Inc.

    Investigators

    • Principal Investigator: Chris Clare, MD, MiMedx Group, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MiMedx Group, Inc.
    ClinicalTrials.gov Identifier:
    NCT02033824
    Other Study ID Numbers:
    • AFCRAN001
    First Posted:
    Jan 13, 2014
    Last Update Posted:
    Aug 23, 2018
    Last Verified:
    Aug 1, 2018
    Additional relevant MeSH terms:
    Cicatrix

    Study Results

    No Results Posted as of Aug 23, 2018