Kerlix Gauze Study in a Burn Trauma Unit and Its Effect on Healthcare Associated Infections in Burn Patients - Full Text View

Sponsors and Collaborators:	University of Iowa Covidien
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00656708

Purpose

The purpose of this study is to determine whether Kerlix AMD gauze will decrease the incidence of healthcare associated infections in burn patients. Kerlix AMD gauze will be applied to all patients with open wounds admitted to the burn unit during the prospective portion of the study. All consenting patients will be assessed for hospital associated infections and outcomes. We hypothesis that burn patients will have a decreased number of hospital associated infections compared to historical controls.

Condition	Intervention	Phase
Burns Wounds	Other: Kerlix AMD gauze	Phase II

MedlinePlus related topics: Burns Injuries Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Kerlix AMD Gauze Study In A Burn Trauma Unit and Its Effect on Healthcare Associated Infections in Burn Patients

Further study details as provided by University of Iowa:

Primary Outcome Measures:

The primary endpoint is the incidence of healthcare associated infections in the study of the acute burn population when using Kerlix AMD gauze as compared to that in matched historical controls when using standard, non-impregnated gauze. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the incidence of wound infections between the acute burn study patients and the matched historical control patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Compare the incidence of healthcare associated infections in the unit when using Kerlix AMD to the previous year using standard gauze. Epidemiology infection rates will be used to compare the incidence of infections. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Compare the presence of pathogenic organisms on weekly wound swabs between the acute burn study patients and the matched historical control patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Compare the nasal MSSA/MRSA colonization between the acute burn study patients and the matched historical control patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Compare the incidence of rectal VRE colonization between the acute burn study patients and the matched historical control patients. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Compare the length of stay per body surface area burned between the acute burn study patients and the matched historical control patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Compare the antibiotic usage between the acute burn study patients and the matched historical control patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	432
Study Start Date:	April 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PB: Experimental All patients admitted to the burn unit during the prospective portion (interventional portion) of the study who have open wounds will have Kerlix AMD applied to their wounds; only those patients consenting to the study will have data abstracted.	Other: Kerlix AMD gauze Use Kerlix AMD gauze as the wound dressing for the entire burn unit

Detailed Description:

Infection continues to cause significant morbidity in burn patients. Among critically ill patient populations, burn patients have some of the highest rates of device related infections. The loss of integument accompanied with the immunosuppression of the burn injury makes burn patients highly susceptible to infection. Despite the use of daily hydrotherapy, topical antimicrobials and early surgical intervention, sepsis frequently occurs. The burn wound is a major source of nosocomial infections. The standard burn wound dressing at UIHC consists of silver sulfadiazine cream and an outer dressing of woven, porous gauze. A newer version of woven, porous gauze, KERLIX AMD, Covidien, Mansfield, MA, offers additional protection for wounds that require dressing or packing. KERLIX AMD differs from plain gauze only in its impregnation with 0.2% polyhexamethylene biguanide (PHMB). PHMB is chemically related to chlorhexidine gluconate (CHG) which is a biguanide. PHMB has been used as a broad spectrum antiseptic in products such as pool cleaners. Further, PHMB is a broad spectrum biocide that is active against a wide range of pathogens that includes MRSA, VRE, Candida albicans, Pseudomonas aeruginosa, multi-drug resistant Acinetobacter as well as many other pathogens. Clinical exposure is several orders of magnitude less than that associated with acute toxicity (6.46 mg/PHMB/kg v 400 mg PHMB/kg). Clinical use of KERLIX AMD has shown a decrease in wound colonization and a decrease in surgical site infections in multiple wound types. We hypothesize that Kerlix AMD dressing will decrease the incidence of nosocomial infections in our burn patients.

Upon admission to the burn unit, all patients with open wounds will have their wounds dressed with KERLIX AMD Gauze. Patients will then be approached to have their data collected and analyzed for the study. Only patients consenting to the study will have their data collected.

The gauze will be applied directly to all open torso or extremity wounds over a layer of Silver Sulfadiazine immediately after admission to 8JC. The gauze will be used until wounds no longer require dressing. There will be no restriction on the use of topical antibiotics, although Dakin's solution will be restricted. Studies have shown that Dakin's solution deactivates the PHMB.( Tyco Healthcare Group LP) There will be no restriction on the outer layers of the wound dressing or the frequency of dressing changes.

When 108 burn subjects have completed enrollment, the study will be stopped and the data analyzed. Historical infection data will be obtained by reviewing the charts of the last 324 burn patients (with LOS>48 hours) prior to study commencement. Historical data will be compared to the KERLIX AMD gauze study data. All data analyses will be conducted by a biostatistician. Infections will be defined by modified Centers for Disease Control (CDC) criteria.10

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

admitted to the burn unit with a burn or open wound and anticipated to have a length of stay greater than 48 hours

Exclusion Criteria:

pregnant or nursing women
wound is considered unsuitable for study dressings as determined by primary physician
use of Dakin's solution on wound

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656708

Contacts

Contact: Lucy A Wibbenmeyer, MD	319-356-3551	lucy-wibbenmeyer@uiowa.edu
Contact: Ingrid M Williams, MD	319-356-1304	ingrid-williams@uiowa.edu

Locations

United States, Iowa
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

University of Iowa

Covidien

Investigators

Principal Investigator:

Lucy A Wibbenmeyer, MD

The University of Iowa Hospitals & Clinics

More Information

Publications:

Appelgren P, Björnhagen V, Bragderyd K, Jonsson CE, Ransjö U. A prospective study of infections in burn patients. Burns. 2002 Feb;28(1):39-46.

Taylor GD, Kibsey P, Kirkland T, Burroughs E, Tredget E. Predominance of staphylococcal organisms in infections occurring in a burns intensive care unit. Burns. 1992 Aug;18(4):332-5.

Wibbenmeyer L, Danks R, Faucher L, Amelon M, Latenser B, Kealey GP, Herwaldt LA. Prospective analysis of nosocomial infection rates, antibiotic use, and patterns of resistance in a burn population. J Burn Care Res. 2006 Mar-Apr;27(2):152-60.

Wurtz R, Karajovic M, Dacumos E, Jovanovic B, Hanumadass M. Nosocomial infections in a burn intensive care unit. Burns. 1995 May;21(3):181-4.

[No authors listed] National Nosocomial Infections Surveillance (NNIS) System Report, Data Summary from January 1992-June 2001, issued August 2001. Am J Infect Control. 2001 Dec;29(6):404-21. No abstract available.

Stone PW, Braccia D, Larson E. Systematic review of economic analyses of health care-associated infections. Am J Infect Control. 2005 Nov;33(9):501-9. Review.

Mayhall CG: The epidemology of burn wound infections: then and now. Clinical infectious diseases 15937):543-50, 2003

Motta GJ, Milne CT, Corbett LQ. Impact of antimicrobial gauze on bacterial colonies in wounds that require packing. Ostomy Wound Manage. 2004 Aug;50(8):48-62.

Motta GJ, Trigilia D. The effect of an antimicrobial drain sponge dressing on specific bacterial isolates at tracheostomy sites. Ostomy Wound Manage. 2005 Jan;51(1):60-2, 64-6.

Garner JS, Jarvis WR, Emori TG, Horan TC, Hughes JM. CDC definitions for nosocomial infections, 1988. Am J Infect Control. 1988 Jun;16(3):128-40. Erratum in: Am J Infect Control 1988 Aug;16(4):177.

Responsible Party:	University of Iowa Hospitals & Clinics ( Lucy A. Wibbenmeyer, MD )
Study ID Numbers:	359.22
Study First Received:	April 7, 2008
Last Updated:	April 10, 2008
ClinicalTrials.gov Identifier:	NCT00656708
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Iowa:

Burns
Wounds
Healthcare associated infections
MRSA
VRE

Study placed in the following topic categories:

Burns
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009