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Sponsored by: |
The University of Texas, Galveston |
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Information provided by: | The University of Texas, Galveston |
ClinicalTrials.gov Identifier: | NCT00675922 |
Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound healing, length of hospital stay).
Condition | Intervention | Phase |
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Burn |
Drug: Sulfamylon Solution 5% Drug: Dakins 0.025% solution Drug: Cerium solution Drug: Silver Nitrate |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparing the Use of Sulfamylon 5%, Dakins 0.025%, Cerium, Silver Nitrate 5% and/or Other Topical Antimicrobial Products for the Treatment of Excised and/or Grafted Burn Wounds |
Estimated Enrollment: | 200 |
Study Start Date: | July 1995 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Application of Sulfamylon 5% Solution
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Drug: Sulfamylon Solution 5%
Application of Sulfamylon Solution to burn wound daily
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2: Experimental
Application of Dakins 0.025% Solution
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Drug: Dakins 0.025% solution
Application of Dakins solution to burn wound daily.
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3: Experimental
Application of Cerium Solution
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Drug: Cerium solution
cerium solution applied to burn wounds daily.
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4: Experimental
Application of Silver Nitrate Solution
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Drug: Silver Nitrate
Silver Nitrate solution applied to burn wounds daily
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Ages Eligible for Study: | up to 90 Years |
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, 77555 | |
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 ( David N. Herndon, MD ) |
Study ID Numbers: | 95-096 |
Study First Received: | December 26, 2007 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00675922 History of Changes |
Health Authority: | United States: Institutional Review Board |
Burn Wounds Wound infection Topical antimicrobials |
Cerium Dakins Sulfamylon Soaks Silver Nitrate |
Burns Anti-Infective Agents, Local Anti-Infective Agents Sodium Hypochlorite Wounds and Injuries |
Mafenide Silver Nitrate Disorders of Environmental Origin Eusol Wound Infection |
Burns Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Wounds and Injuries |
Mafenide Silver Nitrate Disorders of Environmental Origin Pharmacologic Actions |