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Use of Amnion on Partial Thickness Burns (Amnion)

This study has been withdrawn prior to enrollment.
(Hurricane- terminated study due to skin bank being destroyed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00674999
First Posted: May 8, 2008
Last Update Posted: November 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
  Purpose
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.

Condition Intervention Phase
Burn Biological: Amnion Drug: Polysporin/Bacitracin/Mycostatin Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Project Title The Treatment of Partial Thickness Burns: Treated Amnion Versus Currently in Use Topical Medications

Resource links provided by NLM:


Further study details as provided by The University of Texas Medical Branch, Galveston:

Primary Outcome Measures:
  • Length of time to 95% healing of treated burn wounds [ Time Frame: Assessment daily until 95 % healed ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: Measured at hospital discharge ]
  • Incidence of infection [ Time Frame: 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. ]
  • Amount of scaring with different treatments [ Time Frame: From injury to 2 years post burn ]

Enrollment: 0
Study Start Date: June 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: 2
Amnion with processing procedures involving the use of Dispase II
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not expected to survive
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674999


Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Principal Investigator: David N Herndon, MD University of Texas
  More Information

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00674999     History of Changes
Other Study ID Numbers: 05-040
First Submitted: December 26, 2007
First Posted: May 8, 2008
Last Update Posted: November 15, 2012
Last Verified: November 2012

Keywords provided by The University of Texas Medical Branch, Galveston:
Burn
Partial thickness burn

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Bacitracin
Nystatin
Anti-Infective Agents, Local
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action