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

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ClinicalTrials.gov Identifier: NCT00675922
Recruitment Status : Terminated (Data inconclusive.)
First Posted : May 12, 2008
Results First Posted : January 18, 2013
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound healing, length of hospital stay).

Condition or disease Intervention/treatment Phase
Burn Drug: Sulfamylon 5% and Silver Nitrate Soaks Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
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
Study Start Date : July 1995
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients [ Time Frame: Admission to burn unit to discharge ]


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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Older Adult)
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

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

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00675922     History of Changes
Other Study ID Numbers: 95-096
First Posted: May 12, 2008    Key Record Dates
Results First Posted: January 18, 2013
Last Update Posted: October 4, 2018
Last Verified: August 2018
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:
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Burns
Wounds and Injuries
Silver Nitrate
Mafenide
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action