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

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

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