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

This study has been completed.
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston Identifier:
First received: December 26, 2007
Last updated: June 23, 2014
Last verified: June 2014

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
Early Phase 1

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

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


Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Medical Branch, Galveston
Principal Investigator: David N Herndon, MD University of Texas
  More Information

Responsible Party: The University of Texas Medical Branch, Galveston Identifier: NCT00592189     History of Changes
Other Study ID Numbers: 1999-209
Study First Received: December 26, 2007
Last Updated: June 23, 2014

Keywords provided by The University of Texas Medical Branch, Galveston:
Wound healing
Amnion processed this record on May 25, 2017