Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring

MiMedx

Status: Completed

Conditions: Scarring

Treatments: Other: dHACM; Procedure: Craniectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02033824

AFCRAN001

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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7 participants in 2 patient groups

Group 1 Control

Other group

Description:

Will receive only traditional craniectomy

Treatment:

Procedure: Craniectomy

Group 2 Treatment dHACM

Experimental group

Description:

Will receive craniectomy, but with the addition of a piece of dHACM placed over any dural defect or dural closure.

Treatment:

Procedure: Craniectomy

Other: dHACM