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NCT00592189 Clinical Trial

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

Wounds Clinical Trial

— Amnion  

Official title:
Fetal Membrane as a New Coverage Material

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00592189
Other study ID # 1999-209
Secondary ID Clayton
Status Completed
Phase Phase 0
First received December 26, 2007
Last updated June 23, 2014
Start date December 1999
Est. completion date June 2014

Study information
Verified date June 2014
Source The University of Texas Medical Branch, Galveston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1164
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria:

- Women

- Pregnant, delivery expected within the month

Exclusion Criteria:

- Known history of hepatitis, HIV, or active transmissable diseases

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Procedure:
• blood draw
blood collection

Locations
Country Name City State
United States University of Texas Medical Branch Galveston Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safe method of obtaining and processing amnion 0-21 days post harvest Yes
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