Scarring
Conditions
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.
Interventions
OTHERdHACM
A piece of dHACM placed over any dural defect or dural closure during craniectomy.
PROCEDURECraniectomy
Removal of the skull flap followed by closure techniques per current SOC.
Sponsors
MiMedx Group, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Intra- and post-operative complications at reoperation, as assessed by occurrence of violation of the dura and/or violation of the parenchyma. | 6 Months |
| Post-operative complications at original and re-operation | 6 Months |
| Peri-operative measures at original and re-operation | 6 Months |
| Survival | 6 Months |
Countries
United States
Outcome results
None listed