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Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks

This study has been terminated.
(Data inconclusive.)
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00675922
First received: December 26, 2007
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Burns
U.S. FDA Resources

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

Primary Outcome Measures:
  • Infection Rate [ Time Frame: Acute hospitalization following burn injury: admission to discharge (1-20 weeks) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00675922

Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
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: The University of Texas, Galveston
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Silver Nitrate
Mafenide
 Anti-Infective Agents
Anti-Infective Agents, Local
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013