Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring

Completed · Not applicable

Conditions studied: Scarring

In brief

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.

Key facts

Study ID

NCT02033824

Run by

MiMedx Group, Inc.

People needed

7

Starts

2014-04-01

Expected to finish

2018-06-01

Last updated by the study team

2018-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Boulder Neurological Associates — Boulder, Colorado, United States
• Chattanooga Center for Neurological Research — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.