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Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks (Soaks)

This study has been terminated.
(Data inconclusive.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00675922
First Posted: May 12, 2008
Last Update Posted: January 18, 2013
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
Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound healing, length of hospital stay).

Condition Intervention Phase
Burn Drug: Sulfamylon 5% and Silver Nitrate Soaks Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Infection Rate [ Time Frame: Acute hospitalization following burn injury: admission to discharge (1-20 weeks) ]
    Percent of infections following antimicrobial topical treatment with Sulfamylon vs Silver Nitrate Soaks.


Secondary Outcome Measures:
  • Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients [ Time Frame: Admission to burn unit to discharge ]

Enrollment: 98
Study Start Date: July 1995
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sulfamylon 5% and Silver Nitrate Soaks
Application of Sulfamylon 5% Solution and Silver Nitrate soaked dressings to two different burned area. Sites were then monitored for infections during hospitalization.
Drug: Sulfamylon 5% and Silver Nitrate Soaks
Application of Sulfamylon and Silver Nitrate Solution to burn wound daily
Other Names:
  • Sulfamylon
  • Silver Nitrate

Detailed Description:
Patients were treated with both Sulfamylon soaks and Silver nitrate soaks on different burn areas. These two areas were then compared for incidence (percentage) of infections.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Burn Injury requiring excisional therapy
  • Hospitalization required until wounds are closed

Exclusion Criteria:

  • Known hypersensitivity to products
  • Outpatient treatment for burn injury
  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): NCT00675922


Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
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: NCT00675922     History of Changes
Other Study ID Numbers: 95-096
First Submitted: December 26, 2007
First Posted: May 12, 2008
Results First Submitted: August 6, 2012
Results First Posted: January 18, 2013
Last Update Posted: January 18, 2013
Last Verified: December 2012

Keywords provided by The University of Texas Medical Branch, Galveston:
Burn
Wounds
Wound infection
Topical antimicrobials
Cerium
Dakins
Sulfamylon Soaks
Silver Nitrate

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Anti-Infective Agents
Silver Nitrate
Mafenide
Anti-Bacterial Agents
Anti-Infective Agents, Local