NCT00592189

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,164

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 1999

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

14.5 years

First QC Date

December 26, 2007

Last Update Submit

June 23, 2014

Conditions

Wounds

Keywords

BurnsWound healingAmnion

Outcome Measures

Primary Outcomes (1)

  • Safe method of obtaining and processing amnion

    0-21 days post harvest

Study Arms (1)

1

EXPERIMENTAL

Amnion tissue and blood collection

Procedure: blood draw

Interventions

blood drawPROCEDURE

blood collection

1

Eligibility Criteria

Age16 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women
  • Pregnant, delivery expected within the month

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Wounds and InjuriesBurns

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • David N Herndon, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 11, 2008

Study Start

December 1, 1999

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations

US(1)