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

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

MedlinePlus related topics:

Burns

Drug Information available for:

Silver nitrate Mafenide Mafenide acetate Sodium hypochlorite

U.S. FDA Resources

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

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

Ages Eligible for Study:	up to 90 Years
Genders Eligible for Study:	Both
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

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

Responsible Party:	University of Texas Medical Branch ( David N. Herndon, MD )
Study ID Numbers:	95-096
First Received:	December 26, 2007
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00675922
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

Sodium Hypochlorite

Wounds and Injuries

Mafenide

Silver Nitrate

Disorders of Environmental Origin

Eusol

Wound Infection

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Infective Agents, Local

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2008

Sponsored by:	The University of Texas, Galveston
Information provided by:	The University of Texas, Galveston
ClinicalTrials.gov Identifier:	NCT00675922