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

June 15, 2023 updated by: The University of Texas Medical Branch, Galveston

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Known hypersensitivity to products
  • Outpatient treatment for burn injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Silver Nitrate
  • Sulfamylon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Acute hospitalization following burn injury: admission to discharge (1-20 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients
Time Frame: Admission to burn unit to discharge
At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data for this outcome. Although peer-reviewed articles have been located that reference NCT00675922 it is not clear and verifiable (without access to the actual study-related data) what the results for this outcome.
Admission to burn unit to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Investigators

  • Principal Investigator: David N Herndon, MD, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1995

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

May 7, 2008

First Posted (Estimated)

May 12, 2008

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 95-096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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