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

Fetal Membrane as a New Coverage Material

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00592189

Acronym

Amnion

Enrollment

1164

Registered

2008-01-11

Start date

1999-12-31

Completion date

2014-06-30

Last updated

2014-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounds

Keywords

Burns, Wound healing, Amnion

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.

Interventions

PROCEDUREblood draw

blood collection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Women * Pregnant, delivery expected within the month

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safe method of obtaining and processing amnion	0-21 days post harvest

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026