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

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Wounds

Treatments: Procedure: blood draw

Study type: Interventional

Funder types: Other

Identifiers

NCT00592189

1999-209

Clayton

Details and patient eligibility

About

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.

Enrollment: 1,164 patients

Sex: Female

Ages: 16 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women
• Pregnant, delivery expected within the month

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,164 participants in 1 patient group

1

Experimental group

Description:

Amnion tissue and blood collection

Treatment:

Procedure: blood draw