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

Early Phase 1

Completed

• Conditions: Wounds
• Interventions: Procedure: blood draw

• Registration Number: NCT00592189
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-12
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-11
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1164

Inclusion Criteria

• Women
• Pregnant, delivery expected within the month

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	blood draw	Amnion tissue and blood collection

Primary Outcome Measures

Name	Time	Method
Safe method of obtaining and processing amnion	0-21 days post harvest

Trial Locations

Locations (1)

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States