Trials / Completed
CompletedNCT02033824
Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring
A Multicenter Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane dHACM in Decompressive Craniectomy Patients to Reduce Postoperative Scarring
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- MiMedx Group, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | dHACM | A piece of dHACM placed over any dural defect or dural closure during craniectomy. |
| PROCEDURE | Craniectomy | Removal of the skull flap followed by closure techniques per current SOC. |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
- First posted
- 2014-01-13
- Last updated
- 2018-08-23
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02033824. Inclusion in this directory is not an endorsement.