Back to resultsAmniotic Membrane in Decompressive Craniectomy to Reduce Scarring
Primary Purpose
Scarring
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dHACM
Craniectomy
Sponsored by
About this trial
This is an interventional treatment trial for Scarring
Eligibility 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
Sites / Locations
- Boulder Neurological Associates
- Chattanooga Center for Neurological Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Group 1 Control
Group 2 Treatment dHACM
Arm Description
Will receive only traditional craniectomy
Will receive craniectomy, but with the addition of a piece of dHACM placed over any dural defect or dural closure.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Intra- and post-operative complications at reoperation, as assessed by occurrence of violation of the dura and/or violation of the parenchyma.
Post-operative complications at original and re-operation
Peri-operative measures at original and re-operation
Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02033824
Brief Title
Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring
Official Title
A Multicenter Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane dHACM in Decompressive Craniectomy Patients to Reduce Postoperative Scarring
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MiMedx Group, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scarring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 Control
Arm Type
Other
Arm Description
Will receive only traditional craniectomy
Arm Title
Group 2 Treatment dHACM
Arm Type
Experimental
Arm Description
Will receive craniectomy, but with the addition of a piece of dHACM placed over any dural defect or dural closure.
Intervention Type
Other
Intervention Name(s)
dHACM
Other Intervention Name(s)
AmnioFix®
Intervention Description
A piece of dHACM placed over any dural defect or dural closure during craniectomy.
Intervention Type
Procedure
Intervention Name(s)
Craniectomy
Other Intervention Name(s)
Decompressive Craniectomy
Intervention Description
Removal of the skull flap followed by closure techniques per current SOC.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Post-operative complications at original and re-operation
Time Frame
6 Months
Title
Peri-operative measures at original and re-operation
Time Frame
6 Months
Title
Survival
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Clare, MD
Organizational Affiliation
MiMedx Group, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boulder Neurological Associates
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Chattanooga Center for Neurological Research
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
12. IPD Sharing Statement
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Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring
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