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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00656708
First Posted: April 11, 2008
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Lucy A Wibbenmeyer, University of Iowa
  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
Burns Wounds Other: Kerlix AMD gauze

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Kerlix AMD Gauze Study In A Burn Trauma Unit and Its Effect on Healthcare Associated Infections in Burn Patients

Resource links provided by NLM:


Further study details as provided by Lucy A Wibbenmeyer, 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 ]

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 ]
  • 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 ]
  • 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 ]
  • Compare the nasal MSSA/MRSA colonization between the acute burn study patients and the matched historical control patients. [ Time Frame: 2 years ]
  • Compare the incidence of rectal VRE colonization between the acute burn study patients and the matched historical control patients. [ Time Frame: 2 years ]
  • 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 ]
  • Compare the antibiotic usage between the acute burn study patients and the matched historical control patients. [ Time Frame: 2 years ]

Enrollment: 108
Study Start Date: August 2008
Study Completion Date: January 2011
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PB
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
Other Name: Kerlix Gauze

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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656708


Locations
United States, Iowa
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Medtronic - MITG
Investigators
Principal Investigator: Lucy A Wibbenmeyer, MD The University of Iowa Hospitals & Clinics
  More Information

Publications:

Responsible Party: Lucy A Wibbenmeyer, Clinical Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT00656708     History of Changes
Other Study ID Numbers: 359.22
First Submitted: April 7, 2008
First Posted: April 11, 2008
Last Update Posted: April 21, 2017
Last Verified: August 2009
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lucy A Wibbenmeyer, University of Iowa:
Burns
Wounds
Healthcare associated infections
MRSA
VRE

Additional relevant MeSH terms:
Infection
Burns
Cross Infection
Wounds and Injuries
Iatrogenic Disease
Disease Attributes
Pathologic Processes