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Study of Donated Amnion, Fetal Placental Membrane, as Skin Substitute for Burn Patients (Amnion)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00592189
First Posted: January 11, 2008
Last Update Posted: June 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
  Purpose

Is the use of fetal membrane (human amnion) as a transient wound coverage in wound repair safe and efficacious.

Will the incorporation of liposomal gene constructs to amnion enhance the functionality of human amnion and improve wound repair.


Condition Intervention Phase
Wounds Procedure: blood draw Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Fetal Membrane as a New Coverage Material

Further study details as provided by The University of Texas Medical Branch, Galveston:

Primary Outcome Measures:
  • Safe method of obtaining and processing amnion [ Time Frame: 0-21 days post harvest ]

Enrollment: 1164
Study Start Date: December 1999
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Amnion tissue and blood collection
Procedure: blood draw
blood collection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women
  • Pregnant, delivery expected within the month

Exclusion Criteria:

  • Known history of hepatitis, HIV, or active transmissable diseases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592189


Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Principal Investigator: David N Herndon, MD University of Texas
  More Information

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00592189     History of Changes
Other Study ID Numbers: 1999-209
Clayton
First Submitted: December 26, 2007
First Posted: January 11, 2008
Last Update Posted: June 24, 2014
Last Verified: June 2014

Keywords provided by The University of Texas Medical Branch, Galveston:
Burns
Wound healing
Amnion