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Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring

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ClinicalTrials.gov Identifier: NCT02033824
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.

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
Scarring Other: dHACM Procedure: Craniectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : April 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Group 1 Control
Will receive only traditional craniectomy
Procedure: Craniectomy
Removal of the skull flap followed by closure techniques per current SOC.
Other Name: 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 Name: AmnioFix®

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




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. [ Time Frame: 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. [ Time Frame: 6 Months ]
  2. Post-operative complications at original and re-operation [ Time Frame: 6 Months ]
  3. Peri-operative measures at original and re-operation [ Time Frame: 6 Months ]
  4. Survival [ Time Frame: 6 Months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033824


Locations
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United States, Colorado
Boulder Neurological Associates
Boulder, Colorado, United States, 80303
United States, Tennessee
Chattanooga Center for Neurological Research
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
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Principal Investigator: Chris Clare, MD MiMedx Group, Inc.

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Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT02033824     History of Changes
Other Study ID Numbers: AFCRAN001
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes