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

• Sponsor: The University of Texas Medical Branch, Galveston (Other)
• Overall Status: Completed
• CT.gov ID: NCT00592189
• Collaborator: (none)
• Enrollment: 1,164
• Location: 1
• Arm: 1
• Duration (Months): 174
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Wounds	Procedure: blood draw	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 1164 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Fetal Membrane as a New Coverage Material
• Study Start Date: Dec 1, 1999
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Amnion tissue and blood collection	Procedure: blood draw; blood collection

Outcome Measures

Primary Outcome Measures

1. Safe method of obtaining and processing amnion [0-21 days post harvest]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 65 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT00592189
• Other Study ID Numbers: 1999-209; Clayton
• First Posted: Jan 11, 2008
• Last Update Posted: Jun 24, 2014
• Last Verified: Jun 1, 2014

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

Study Results

No Results Posted as of Jun 24, 2014