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

Sponsor:	The University of Texas, Galveston
Information provided by (Responsible Party):	The University of Texas, Galveston
ClinicalTrials.gov Identifier:	NCT00675922

Purpose

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

Condition	Intervention	Phase
Burn	Drug: Sulfamylon Solution 5% Drug: Dakins 0.025% solution Drug: Cerium solution Drug: Silver Nitrate	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel 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

Drug Information available for: Mafenide acetate Mafenide Silver nitrate Lunar caustic

U.S. FDA Resources

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

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

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: 1 Application of Sulfamylon 5% Solution	Drug: Sulfamylon Solution 5% Application of Sulfamylon Solution to burn wound daily Other Name: Sulfamylon
Experimental: 2 Application of Dakins 0.025% Solution	Drug: Dakins 0.025% solution Application of Dakins solution to burn wound daily. Other Name: Sodium hypochloride
Experimental: 3 Application of Cerium Solution	Drug: Cerium solution cerium solution applied to burn wounds daily. Other Name: cerium
Experimental: 4 Application of Silver Nitrate Solution	Drug: Silver Nitrate Silver Nitrate solution applied to burn wounds daily

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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
Last Updated:	December 6, 2011
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 February 12, 2012