NCT02033824

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

4.2 years

First QC Date

November 21, 2013

Last Update Submit

August 22, 2018

Conditions

Scarring

Outcome Measures

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.

    6 Months

Secondary Outcomes (4)

  • 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

Study Arms (2)

Group 1 Control

OTHER

Will receive only traditional craniectomy

Procedure: Craniectomy

Group 2 Treatment dHACM

EXPERIMENTAL

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

Other: dHACMProcedure: Craniectomy

Interventions

dHACMOTHER

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

Also known as: AmnioFix®
Group 2 Treatment dHACM
CraniectomyPROCEDURE

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

Also known as: Decompressive Craniectomy
Group 1 ControlGroup 2 Treatment dHACM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Boulder Neurological Associates

Boulder, Colorado, 80303, United States

Location

Chattanooga Center for Neurological Research

Chattanooga, Tennessee, 37403, United States

Location

MeSH Terms

Conditions

Cicatrix

Interventions

CraniotomyDecompressive Craniectomy

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurosurgical ProceduresSurgical Procedures, OperativeDecompression, Surgical

Study Officials

  • Chris Clare, MD

    MiMedx Group, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2013

First Posted

January 13, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

August 23, 2018

Record last verified: 2018-08

Locations

US(2)