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

This study has been terminated.
(Data inconclusive.)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston Identifier:
First received: December 26, 2007
Last updated: December 10, 2012
Last verified: December 2012
Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound healing, length of hospital stay).

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

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

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
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Please refer to this study by its identifier: NCT00675922

United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Principal Investigator: David N Herndon, MD University of Texas
  More Information

Responsible Party: The University of Texas Medical Branch, Galveston Identifier: NCT00675922     History of Changes
Other Study ID Numbers: 95-096
Study First Received: December 26, 2007
Results First Received: August 6, 2012
Last Updated: December 10, 2012

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

Additional relevant MeSH terms:
Wounds and Injuries
Silver Nitrate
Anti-Infective Agents
Anti-Infective Agents, Local processed this record on May 22, 2017