Use of Amnion on Partial Thickness Burns (Amnion)

November 13, 2012 updated by: The University of Texas Medical Branch, Galveston

Project Title The Treatment of Partial Thickness Burns: Treated Amnion Versus Currently in Use Topical Medications

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not expected to survive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Amnion with processing procedures involving the use of trypsin-Edetic Acid(EDTA)
Biological: Amnion
Application of Amnion with processing procedures involving the use of trypsin-EDTA
Biological: Amnion
Application of Amnion with processing procedures involving the use of Dispase II
EXPERIMENTAL: 2
Amnion with processing procedures involving the use of Dispase II
Biological: Amnion
Application of Amnion with processing procedures involving the use of trypsin-EDTA
Biological: Amnion
Application of Amnion with processing procedures involving the use of Dispase II
ACTIVE_COMPARATOR: 3
Prepared Antibiotic ointment Polysporin, Bacitracin and Mycostatin
Drug: Polysporin/Bacitracin/Mycostatin
Application of Prepared antibiotic ointment: Polysporin, Bacitracin and Mycostatin combined

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of time to 95% healing of treated burn wounds
Time Frame: Assessment daily until 95 % healed
Assessment daily until 95 % healed

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: Measured at hospital discharge
Measured at hospital discharge
Incidence of infection
Time Frame: Measure daily until complete wound healing
Measure daily until complete wound healing
Amount of daily pain until wound is healed with different treatments.
Time Frame: Daily until wound is completely healed.
Daily until wound is completely healed.
Amount of scaring with different treatments
Time Frame: From injury to 2 years post burn
From injury to 2 years post burn

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

May 6, 2008

First Posted (ESTIMATE)

May 8, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2012

Last Update Submitted That Met QC Criteria

November 13, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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