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

NCT00656708 | Completed DMC

• 1 other identifier: 200703800
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Wounds

Keywords

Burns; Wounds; Healthcare associated infections; MRSA; VRE

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (7)

• Compare the incidence of wound infections between the acute burn study patients and the matched historical control patients.

  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.

  2 years

• Compare the presence of pathogenic organisms on weekly wound swabs between the acute burn study patients and the matched historical control patients.

  2 years

• Compare the nasal MSSA/MRSA colonization between the acute burn study patients and the matched historical control patients.

  2 years

• Compare the incidence of rectal VRE colonization between the acute burn study patients and the matched historical control patients.

  2 years

Study Arms (1)

PB

EXPERIMENTAL

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

Interventions

Kerlix AMD gauze OTHER

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

Also known as: Kerlix Gauze

PB

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• admitted to the burn unit with a burn or open wound and anticipated to have a length of stay greater than 48 hours

You may not qualify if:

• pregnant or nursing women
• wound is considered unsuitable for study dressings as determined by primary physician
• use of Dakin's solution on wound

Sponsors & Collaborators

• Lucy A Wibbenmeyer: lead
• Medtronic - MITG: collaborator

Study Sites (1)

The University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (10)

• Appelgren P, Bjornhagen V, Bragderyd K, Jonsson CE, Ransjo U. A prospective study of infections in burn patients. Burns. 2002 Feb;28(1):39-46. doi: 10.1016/s0305-4179(01)00070-5.

  PMID: 11834328 BACKGROUND

• Taylor GD, Kibsey P, Kirkland T, Burroughs E, Tredget E. Predominance of staphylococcal organisms in infections occurring in a burns intensive care unit. Burns. 1992 Aug;18(4):332-5. doi: 10.1016/0305-4179(92)90158-q.

  PMID: 1418512 BACKGROUND

• Wibbenmeyer L, Danks R, Faucher L, Amelon M, Latenser B, Kealey GP, Herwaldt LA. Prospective analysis of nosocomial infection rates, antibiotic use, and patterns of resistance in a burn population. J Burn Care Res. 2006 Mar-Apr;27(2):152-60. doi: 10.1097/01.BCR.0000203359.32756.F7.

  PMID: 16566558 BACKGROUND

• Wurtz R, Karajovic M, Dacumos E, Jovanovic B, Hanumadass M. Nosocomial infections in a burn intensive care unit. Burns. 1995 May;21(3):181-4. doi: 10.1016/0305-4179(95)80005-9.

  PMID: 7794498 BACKGROUND

• National Nosocomial Infections Surveillance (NNIS) System Report, Data Summary from January 1992-June 2001, issued August 2001. Am J Infect Control. 2001 Dec;29(6):404-21. doi: 10.1067/mic.2001.119952. No abstract available.

  PMID: 11743489 BACKGROUND

• Stone PW, Braccia D, Larson E. Systematic review of economic analyses of health care-associated infections. Am J Infect Control. 2005 Nov;33(9):501-9. doi: 10.1016/j.ajic.2005.04.246.

  PMID: 16260325 BACKGROUND

• Mayhall CG. The epidemiology of burn wound infections: then and now. Clin Infect Dis. 2003 Aug 15;37(4):543-50. doi: 10.1086/376993. Epub 2003 Jul 30.

  PMID: 12905139 BACKGROUND

• 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.

  PMID: 15356368 BACKGROUND

• 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.

  PMID: 15695836 BACKGROUND

• 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.

  PMID: 2841893 BACKGROUND

MeSH Terms

Conditions

Burns; Wounds and Injuries; Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lucy A Wibbenmeyer, MD

  The University of Iowa Hospitals & Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 11, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: January 1, 2011
• Last Updated: October 12, 2018

Record last verified: 2009-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)