Study of the Treatment of Burn Wounds With Various Antimicrobial Topical Soaks - Tabular View

Tracking Information

First Received Date ^ICMJE

December 26, 2007

Last Updated Date

February 17, 2009

Start Date ^ICMJE

July 1995

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Wound healing with various topical antimicrobial solutions [ Time Frame: Admission to burn unit to 95% wound healing ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00675922 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rate of infections with use of various antimicrobial agents on burn wounds. [ Time Frame: Admission to burn unit to 95% wound healing ] [ Designated as safety issue: No ]
Length of hospital stay with various antimicrobial solutions for burn patients [ Time Frame: Admission to burn unit to discharge ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study of the Treatment of Burn Wounds With Various Antimicrobial Topical Soaks

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Burn

Intervention ^ICMJE

Drug: Sulfamylon Solution 5%
Drug: Dakins 0.025% solution
Drug: Cerium solution
Drug: Silver Nitrate

Study Arms / Comparison Groups

Experimental: Application of Sulfamylon 5% Solution
Experimental: Application of Dakins 0.025% Solution
Experimental: Application of Cerium Solution
Experimental: Application of Silver Nitrate Solution

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Burn Injury requiring excisional therapy
Hospitalization required until wounds are closed

Exclusion Criteria:

Known hypersensitivity to products
Outpatient treatment for burn injury

Gender

Both

Ages

up to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: David N Herndon, MD	409-770-6731	dherndon@utmb.edu
Contact: Deb A Benjamin, RN, MSN	409-770-6731	dbenjami@utmb.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00675922

Responsible Party

David N. Herndon, MD, University of Texas Medical Branch

Study ID Numbers ^ICMJE

95-096

Study Sponsor ^ICMJE

The University of Texas, Galveston

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

David N Herndon, MD

University of Texas

Information Provided By

The University of Texas, Galveston

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP