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

This study is currently recruiting participants.

Verified by The University of Texas, Galveston, February 2009

First Received: December 26, 2007 Last Updated: February 17, 2009 History of Changes

Sponsored by:	The University of Texas, Galveston
Information provided by:	The University of Texas, Galveston
ClinicalTrials.gov Identifier:	NCT00592189

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

MedlinePlus related topics: Burns

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Single Group Assignment
Official Title:	Fetal Membrane as a New Coverage Material

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 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Amnion tissue and blood collection	Procedure: blood draw blood collection

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592189

Contacts

Contact: David N Herndon, MD	409-770-6731	dherndon@utmb.edu
Contact: Deb A Benjamin, RN, MSN	409-770-6731	dbenjami@utmb.edu

Locations

United States, Texas
University of Texas Medical Branch	Recruiting
Galveston, Texas, United States, 77555
Contact: Deb A Benjamin, RN, MSN 409-770-6731 dbenjami@utmb.edu
Contact: Carole J Miller 409-770-6728 cmiller@utmb.edu

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:	University of Texas Medical Branch, Galveston ( David N. Herndon, MD )
Study ID Numbers:	1999-209, Clayton
Study First Received:	December 26, 2007
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00592189 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:

Burns
Wound healing
Amnion

Study placed in the following topic categories:

Burns

ClinicalTrials.gov processed this record on May 07, 2009