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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
The University of Texas, Galveston Identifier:
First received: December 26, 2007
Last updated: December 12, 2013
Last verified: December 2013

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
Procedure: blood draw
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Fetal Membrane as a New Coverage Material

Resource links provided by NLM:

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

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

Estimated Enrollment: 1500
Study Start Date: December 1999
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Amnion tissue and blood collection
Procedure: blood draw
blood collection


Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Women
  • Pregnant, delivery expected within the month

Exclusion Criteria:

  • Known history of hepatitis, HIV, or active transmissable diseases
  Contacts and Locations
Please refer to this study by its identifier: NCT00592189

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

No publications provided

Responsible Party: The University of Texas, Galveston Identifier: NCT00592189     History of Changes
Other Study ID Numbers: 1999-209, Clayton
Study First Received: December 26, 2007
Last Updated: December 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
Wound healing
Amnion processed this record on April 16, 2014