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

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.

Study Overview

• Status: Completed
• Conditions: Scarring
• Intervention / Treatment: Procedure: Craniectomy; Other: dHACM

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80303
      • Boulder Neurological Associates
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Chattanooga center for neurological research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1 Control; Will receive only traditional craniectomy	Procedure: Craniectomy; Removal of the skull flap followed by closure techniques per current SOC.; Other Names: Decompressive Craniectomy
Experimental: Group 2 Treatment dHACM; Will receive craniectomy, but with the addition of a piece of dHACM placed over any dural defect or dural closure.	Procedure: Craniectomy; Removal of the skull flap followed by closure techniques per current SOC.; Other Names: Decompressive Craniectomy; Other: dHACM; A piece of dHACM placed over any dural defect or dural closure during craniectomy.; Other Names: AmnioFix®

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.
• Investigators: Principal Investigator: Chris Clare, MD, MiMedx Group, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimate): January 13, 2014

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: AFCRAN001