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

Sponsored by:	The University of Texas, Galveston
Information provided by:	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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	200
Study Start Date:	July 1995
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Application of Sulfamylon 5% Solution	Drug: Sulfamylon Solution 5% Application of Sulfamylon Solution to burn wound daily
2: Experimental Application of Dakins 0.025% Solution	Drug: Dakins 0.025% solution Application of Dakins solution to burn wound daily.
3: Experimental Application of Cerium Solution	Drug: Cerium solution cerium solution applied to burn wounds daily.
4: Experimental 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

Contacts

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

Locations

United States, Texas
University of Texas Medical Branch	Recruiting
Galveston, Texas, United States, 77555
Contact: Deb A Benjamin, RN, MSN 409-770-6731 dbenjami@utmb.edu
Contact: Carole J Miller 409-770-6728 cmiller@utmb.edu
Principal Investigator: David N Herndon, MD

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:	University of Texas Medical Branch ( David N. Herndon, MD )
Study ID Numbers:	95-096
Study First Received:	December 26, 2007
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00675922 History of Changes
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

Study placed in the following topic categories:

Burns
Anti-Infective Agents, Local
Sodium Hypochlorite
Wounds and Injuries
Mafenide

Silver Nitrate
Disorders of Environmental Origin
Eusol
Wound Infection

Additional relevant MeSH terms:

Burns
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Wounds and Injuries

Mafenide
Silver Nitrate
Disorders of Environmental Origin
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009