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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Kerlix AMD Gauze Study In A Burn Trauma Unit and Its Effect on Healthcare Associated Infections in Burn Patients

Brief Summary: 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.

Detailed Summary:

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
Sponsor: University of Iowa

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University of Iowa

Dates:
Date Received: April 7, 2008
Date Started: August 2008
Date Completion:
Last Updated: April 19, 2017
Last Verified: August 2009