Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring

Scarring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033824
• Other study ID #: AFCRAN001
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: June 2018

Study information

• Verified date: August 2018
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• Scarring

Intervention

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.

Locations

Country	Name	City	State
United States	Boulder Neurological Associates	Boulder	Colorado
United States	Chattanooga Center for Neurological Research	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intra- and post-operative complications at reoperation, as assessed by occurrence of violation of the dura and/or violation of the parenchyma.		6 Months
Secondary	Post-operative complications at original and re-operation		6 Months
Secondary	Peri-operative measures at original and re-operation		6 Months
Secondary	Survival		6 Months