Overview

This trial is active, not recruiting.

Condition scarring
Treatments dhacm, craniectomy
Sponsor MiMedx Group, Inc.
Start date April 2014
End date June 2018
Trial size 40 participants
Trial identifier NCT02033824, AFCRAN001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Other)
Will receive only traditional craniectomy
craniectomy Decompressive Craniectomy
Removal of the skull flap followed by closure techniques per current SOC.
(Experimental)
Will receive craniectomy, but with the addition of a piece of dHACM placed over any dural defect or dural closure.
dhacm AmnioFix®
A piece of dHACM placed over any dural defect or dural closure during craniectomy.
craniectomy Decompressive Craniectomy
Removal of the skull flap followed by closure techniques per current SOC.

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Multicenter Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane dHACM in Decompressive Craniectomy Patients to Reduce Postoperative Scarring
Principal investigator Chris Clare, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by MiMedx Group, Inc..