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

NCT ID: NCT00656708

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-01-31

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 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

Conditions

Burns; Wounds

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Kerlix AMD gauze

Intervention Type: OTHER

Use Kerlix AMD gauze as the wound dressing for the entire burn unit

Interventions

Kerlix AMD gauze

Use Kerlix AMD gauze as the wound dressing for the entire burn unit

Intervention Type: OTHER

Other Intervention Names

Kerlix Gauze

Eligibility 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

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: collaborator

Lucy A Wibbenmeyer

OTHER

Sponsor Role: lead

Responsible Party

Lucy A Wibbenmeyer

Clinical Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lucy A Wibbenmeyer, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Iowa Hospitals & Clinics

Locations

The University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 15356368 (View on PubMed)

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.

Reference Type: BACKGROUND

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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. doi: 10.1016/0196-6553(88)90053-3.

Reference Type: BACKGROUND

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Other Identifiers

200703800

Identifier Type: -

Identifier Source: org_study_id