Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring

Overview

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.

Full Title of Study: “A Multicenter Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane dHACM in Decompressive Craniectomy Patients to Reduce Postoperative Scarring”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2018

Interventions

  • Other: dHACM
    • A piece of dHACM placed over any dural defect or dural closure during craniectomy.
  • Procedure: Craniectomy
    • Removal of the skull flap followed by closure techniques per current SOC.

Arms, Groups and Cohorts

  • Other: Group 1 Control
    • Will receive only traditional 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: 6 Months

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • MiMedx Group, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chris Clare, MD, Principal Investigator, MiMedx Group, Inc.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.