Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring

Not Applicable

Completed

• Conditions: Scarring
• Interventions: Procedure: Craniectomy; Other: dHACM

• Registration Number: NCT02033824
• Lead Sponsor: MiMedx Group, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-13
• Study Start: 2014-04
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 Control	Craniectomy	Will receive only traditional craniectomy
Group 2 Treatment dHACM	Craniectomy	Will receive craniectomy, but with the addition of a piece of dHACM placed over any dural defect or dural closure.
Group 2 Treatment dHACM	dHACM	Will receive craniectomy, but with the addition of a piece of dHACM placed over any dural defect or dural closure.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Post-operative complications at original and re-operation	6 Months
Survival	6 Months
Intra- and post-operative complications at reoperation, as assessed by occurrence of violation of the dura and/or violation of the parenchyma.	6 Months
Peri-operative measures at original and re-operation	6 Months

Trial Locations

Locations (2)

Boulder Neurological Associates; 🇺🇸 Boulder, Colorado, United States

Chattanooga Center for Neurological Research; 🇺🇸 Chattanooga, Tennessee, United States