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Completed

NCT Number: NCT02033824

Amniotic Membrane in Decompressive Craniectomy to Reduce 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.

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Key information

Conditions

Scarring Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boulder Neurological Associates, Boulder, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dHACM

Other

A piece of dHACM placed over any dural defect or dural closure during craniectomy.

Other names: AmnioFix®

Craniectomy

Procedure

Removal of the skull flap followed by closure techniques per current SOC.

Other names: Decompressive Craniectomy

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Post-operative complications at original and re-operation

    Time frame: 6 Months

  3. Peri-operative measures at original and re-operation

    Time frame: 6 Months

  4. Survival

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

MiMedx Group, Inc.

Industry

Registry information

Official study title

A Multicenter Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane dHACM in Decompressive Craniectomy Patients to Reduce Postoperative Scarring

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2014
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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