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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00592189
First received: December 26, 2007
Last updated: June 23, 2014
Last verified: June 2014
  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
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 ]

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

Ages Eligible for Study:   16 Years to 65 Years
Genders 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
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 ClinicalTrials.gov identifier: NCT00592189

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

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00592189     History of Changes
Other Study ID Numbers: 1999-209, Clayton
Study First Received: December 26, 2007
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014