Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
The University of Texas, Galveston |
---|---|
Information provided by: | The University of Texas, Galveston |
ClinicalTrials.gov Identifier: | NCT00674999 |
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 |
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
|
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David N Herndon, MD | 409-770-6731 | dherndon@utmb.edu |
Contact: Deb A Benjamin, RN, MSN | 409-770-6731 | dbenjami@utmb.edu |
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 |
Principal Investigator: | David N Herndon, MD | University of Texas |
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: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00674999 History of Changes |
Health Authority: | United States: Institutional Review Board |
Burn Partial thickness burn |
Burns Anti-Infective Agents Anti-Infective Agents, Local Anti-Bacterial Agents Antifungal Agents |
Wounds and Injuries Disorders of Environmental Origin Nystatin Bacitracin |
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 |