ScarringNCT02033824
Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring
A study testing dHACM and Craniectomy in people with Scarring, run by MiMedx Group, Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scarring
- What is being tested?
- dHACM and Craniectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boulder Neurological Associates
Boulder, Colorado, 80303
Chattanooga Center for Neurological Research
Chattanooga, Tennessee, 37403
About this study
Official title: A Multicenter Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane dHACM in Decompressive Craniectomy Patients to Reduce Postoperative Scarring
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.
- Conditions
- Scarring
- Being tested
- dHACM, Craniectomy
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dHACMOther
Also called AmnioFix®
A piece of dHACM placed over any dural defect or dural closure during craniectomy.
CraniectomyProcedure or surgery
Also called Decompressive Craniectomy
Removal of the skull flap followed by closure techniques per current SOC.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Control | Other | Will receive only traditional craniectomy Receives: Procedure: Craniectomy |
| Group 2 Treatment dHACM | Experimental | Will receive craniectomy, but with the addition of a piece of dHACM placed over any dural defect or dural closure. Receives: Other: dHACM; Procedure: Craniectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (4)
Intra- and post-operative complications at reoperation, as assessed by occurrence of violation of the dura and/or violation of the parenchyma.
Measured: 6 Months
Post-operative complications at original and re-operation
Measured: 6 Months
Peri-operative measures at original and re-operation
Measured: 6 Months
Survival
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Clare, MD, Principal investigator, MiMedx Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033824
- Sponsor's protocol ID
- AFCRAN001
- Status last verified
- Aug 2018
- First submitted
- 21 Nov 2013
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane dHACM in Decompressive Craniectomy Patients to Reduce Postoperative Scarring
- ClinicalTrials.gov ID
- NCT02033824
- Acronym / sponsor ID
- AFCRAN001
- Conditions
- Scarring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Control | Other | Procedure: CraniectomyWill receive only traditional craniectomy |
| Group 2 Treatment dHACM | Experimental | Other: dHACM, Procedure: CraniectomyWill receive craniectomy, but with the addition of a piece of dHACM placed over any dural defect or dural closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dHACMAlso: AmnioFix®A piece of dHACM placed over any dural defect or dural closure during craniectomy. | Other | Group 2 Treatment dHACM |
| CraniectomyAlso: Decompressive CraniectomyRemoval of the skull flap followed by closure techniques per current SOC. | Procedure or surgery | Group 1 Control, Group 2 Treatment dHACM |
Primary outcome
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
4 secondary outcomes
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
Post-operative complications at original and re-operation
Time frame: 6 Months
Peri-operative measures at original and re-operation
Time frame: 6 Months
Survival
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Clare, MD principal investigator
MiMedx Group, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dHACM and Craniectomy in people with Scarring, run by MiMedx Group, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.