MedTrace Logo

Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring

NCT02033824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2018-08-23

No results posted yet for this study

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.

Conditions

  • Scarring

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.

Sponsors & Collaborators

  • MiMedx Group, Inc.

    lead INDUSTRY

Principal Investigators

  • Chris Clare, MD · MiMedx Group, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02033824 on ClinicalTrials.gov