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Use of Amnion on Partial Thickness Burns

NCT ID: NCT00674999

Last Updated: 2012-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-09-30

Brief Summary

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To determine if Amnion, used on partial thickness burn injuries would provide an improvement in rate of healing, pain control and scarring as compared to standard medical treatments.

Detailed Description

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Conditions

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Burn

Keywords

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Burn Partial thickness burn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Amnion with processing procedures involving the use of trypsin-Edetic Acid(EDTA)

Group Type EXPERIMENTAL

Amnion

Intervention Type BIOLOGICAL

Application of Amnion with processing procedures involving the use of trypsin-EDTA

2

Amnion with processing procedures involving the use of Dispase II

Group Type EXPERIMENTAL

Amnion

Intervention Type BIOLOGICAL

Application of Amnion with processing procedures involving the use of Dispase II

3

Prepared Antibiotic ointment Polysporin, Bacitracin and Mycostatin

Group Type ACTIVE_COMPARATOR

Polysporin/Bacitracin/Mycostatin

Intervention Type DRUG

Application of Prepared antibiotic ointment: Polysporin, Bacitracin and Mycostatin combined

Interventions

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Amnion

Application of Amnion with processing procedures involving the use of trypsin-EDTA

Intervention Type BIOLOGICAL

Amnion

Application of Amnion with processing procedures involving the use of Dispase II

Intervention Type BIOLOGICAL

Polysporin/Bacitracin/Mycostatin

Application of Prepared antibiotic ointment: Polysporin, Bacitracin and Mycostatin combined

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Partial thickness burn injury.
* \>2% burn injury.
* Ages 0-100 years.

Exclusion Criteria

* Patients not expected to survive
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David N Herndon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Countries

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United States

Other Identifiers

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05-040

Identifier Type: -

Identifier Source: org_study_id