BurnsNCT00656708
Kerlix Gauze Study in a Burn Trauma Unit and Its Effect on Healthcare Associated Infections in Burn Patients
A study testing Kerlix AMD gauze in people with Burns and Wounds, run by Lucy A Wibbenmeyer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- What is being tested?
- Kerlix AMD gauze
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- admitted to the burn unit with a burn or open wound and anticipated to have a length of stay greater than 48 hours
Who cannot join
- pregnant or nursing women
- wound is considered unsuitable for study dressings as determined by primary physician
- use of Dakin's solution on wound
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
About this study
Official title: Kerlix AMD Gauze Study In A Burn Trauma Unit and Its Effect on Healthcare Associated Infections in Burn Patients
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.
Read the 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
- Being tested
- Kerlix AMD gauze
- Keywords
- Burns, Wounds, Healthcare associated infections, MRSA, VRE
- Medical subject headings
- Burns, Wounds and Injuries, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kerlix AMD gauzeOther
Also called Kerlix Gauze
Use Kerlix AMD gauze as the wound dressing for the entire burn unit
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Kerlix AMD gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (7)
Compare the incidence of wound infections between the acute burn study patients and the matched historical control patients.
Measured: 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.
Measured: 2 years
Compare the presence of pathogenic organisms on weekly wound swabs between the acute burn study patients and the matched historical control patients.
Measured: 2 years
Compare the nasal MSSA/MRSA colonization between the acute burn study patients and the matched historical control patients.
Measured: 2 years
Compare the incidence of rectal VRE colonization between the acute burn study patients and the matched historical control patients.
Measured: 2 years
Compare the length of stay per body surface area burned between the acute burn study patients and the matched historical control patients.
Measured: 2 years
Compare the antibiotic usage between the acute burn study patients and the matched historical control patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucy A Wibbenmeyer
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor-investigator, Lucy A Wibbenmeyer, University of Iowa
- Investigators
- Lucy A Wibbenmeyer, MD, Principal investigator, The University of Iowa Hospitals & Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656708
- Sponsor's protocol ID
- 200703800
- Status last verified
- Aug 2009
- First submitted
- 7 Apr 2008
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
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.
PubMed 11834328Taylor 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.
PubMed 1418512Wibbenmeyer 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.
PubMed 16566558Wurtz 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.
PubMed 7794498National 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.
PubMed 11743489Stone 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.
PubMed 16260325Mayhall 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.
PubMed 12905139Motta 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.
PubMed 15356368Motta 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.
PubMed 15695836Garner 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.
PubMed 2841893
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kerlix AMD Gauze Study In A Burn Trauma Unit and Its Effect on Healthcare Associated Infections in Burn Patients
- ClinicalTrials.gov ID
- NCT00656708
- Acronym / sponsor ID
- 200703800
- Keywords
- Burns, Wounds, Healthcare associated infections, MRSA, VRE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Lucy A WibbenmeyerUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 11 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PB | Experimental | Other: Kerlix AMD gauzeAll 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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- admitted to the burn unit with a burn or open wound and anticipated to have a length of stay greater than 48 hours
Key exclusion criteria (3 listed)
- pregnant or nursing women
- wound is considered unsuitable for study dressings as determined by primary physician
- use of Dakin's solution on wound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kerlix AMD gauzeAlso: Kerlix GauzeUse Kerlix AMD gauze as the wound dressing for the entire burn unit | Other | PB |
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Background: PubMed 11834328Appelgren 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.
- Background: PubMed 1418512Taylor 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.
- Background: PubMed 16566558Wibbenmeyer 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.
- Background: PubMed 7794498Wurtz 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.
- Background: PubMed 11743489National 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.
- Background: PubMed 16260325Stone 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.
- Background: PubMed 12905139Mayhall 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.
- Background: PubMed 15356368Motta 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.
- Background: PubMed 15695836Motta 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.
- Background: PubMed 2841893Garner 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.
- Individual participant dataSharing planned: No
Related trials for Burns
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy A Wibbenmeyer, MD principal investigator
The University of Iowa Hospitals & Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kerlix AMD gauze in people with Burns and Wounds, run by Lucy A Wibbenmeyer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00656708, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.