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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University of Iowa.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Covidien
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00656708
First received: April 7, 2008
Last updated: August 18, 2009
Last verified: August 2009
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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: August 2008
Estimated 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Responsible Party: Lucy A. Wibbenmeyer, MD, University of Iowa Hospitals & Clinics
ClinicalTrials.gov Identifier: NCT00656708     History of Changes
Other Study ID Numbers: 359.22
Study First Received: April 7, 2008
Last Updated: August 18, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Burns
Wounds
Healthcare associated infections
MRSA
VRE

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014