Use of Amnion on Partial Thickness Burns - Full Text View

Sponsor:	The University of Texas, Galveston
Information provided by:	The University of Texas, Galveston
ClinicalTrials.gov Identifier:	NCT00674999

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Project Title The Treatment of Partial Thickness Burns: Treated Amnion Versus Currently in Use Topical Medications

Resource links provided by NLM:

MedlinePlus related topics: Burns

Drug Information available for: Polymyxin sulfate salt, mixt. with bacitracin zinc Nystatin Bacitracin Bacitracin zinc

U.S. FDA Resources

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

Primary Outcome Measures:

Length of time to 95% healing of treated burn wounds [ Time Frame: Assessment daily until 95 % healed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Length of hospital stay [ Time Frame: Measured at hospital discharge ] [ Designated as safety issue: No ]
Incidence of infection [ Time Frame: Measure daily until complete wound healing ] [ Designated as safety issue: Yes ]
Amount of daily pain until wound is healed with different treatments. [ Time Frame: Daily until wound is completely healed. ] [ Designated as safety issue: No ]
Amount of scaring with different treatments [ Time Frame: From injury to 2 years post burn ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	June 2005
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Amnion with processing procedures involving the use of trypsin-EDTA	Biological: Amnion Application of Amnion with processing procedures involving the use of trypsin-EDTA
2: Experimental Amnion with processing procedures involving the use of Dispase II	Biological: Amnion Application of Amnion with processing procedures involving the use of Dispase II
3: Active Comparator Prepared Antibiotic ointment Polysporin, Bacitracin and Mycostatin	Drug: Polysporin/Bacitracin/Mycostatin Application of Prepared antibiotic ointment: Polysporin, Bacitracin and Mycostatin combined

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674999

Contacts

Contact: David N Herndon, MD	409-770-6731	dherndon@utmb.edu
Contact: Deb A Benjamin, RN, MSN	409-770-6731	dbenjami@utmb.edu

Locations

United States, Texas
University of Texas Medical Branch	Recruiting
Galveston, Texas, United States, 77550
Contact: Deb A Benjamin, RN, MSN 409-770-6731 dbenjami@utmb.edu
Contact: Carole J Miller 409-770-6728 cmiller@utmb.edu
Principal Investigator: David N Herndon, MD

Sponsors and Collaborators

The University of Texas, Galveston

Investigators

Principal Investigator:

David N Herndon, MD

University of Texas

More Information

No publications provided

Responsible Party:	University of Texas Medical Branch, Galveston ( David N. Herndon, MD )
Study ID Numbers:	05-040
Study First Received:	December 26, 2007
Last Updated:	December 10, 2009
ClinicalTrials.gov Identifier:	NCT00674999 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:

Burn
Partial thickness burn

Additional relevant MeSH terms:

Burns
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Wounds and Injuries
Disorders of Environmental Origin
Nystatin
Bacitracin

Pharmacologic Actions
Membrane Transport Modulators
Anti-Infective Agents, Local
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents
Ionophores

ClinicalTrials.gov processed this record on February 08, 2010