WoundsNCT00203489
A Clinical Study of An Antimicrobial Gauze Dressing
A study testing KERLIX A.M.D. Gauze in people with Wounds, run by Tyco Healthcare Group at 1 site in Canada.
Trial summary
The purpose of this study is to determine if a new antimicrobial gauze dressing is better than the current method of dressing open wounds with plain sterile gauze. It is hoped that the antimicrobial gauze will reduce the number of germs in the open wound and even improve the rate of healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds
- What is being tested?
- KERLIX A.M.D. Gauze
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to Aug 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is receiving care at the study wound care clinics.
- The subject is 18 years of age or older.
- The subject or authorized representative has signed the Informed Consent form.
- The subject has a chronic wound as a result of pressure ulceration (grade III and IV ulcers only), underlying vascular disease ("leg ulcer"), diabetes mellitus (grade 2 and 3 ulcers only), or recent surgery.
Who cannot join
- The subject has a chronic ulcer that is a result of a condition other than that defined in the inclusion criteria.
- The subject has stage I and II pressure ulceration.
- The subject has a superficial (grade 0 or 1) or limb-threatening diabetic foot ulceration (grade 4 or 5).
- The subject has a leg ulcer related to carcinoma.
- The subject is scheduled to go for amputation or surgical flap procedure as a result of an open wound.
- Subject is scheduled to receive a V.A.C.® (Vacuum Assisted Closure) Dressing [V.A.C.® (Vacuum Assisted Closure) Dressing KCI, Kinetic Concepts, Inc., San Antonio, TX].
Show all 11Show fewer
- The subject has extensive burns or another acute diffuse skin condition (Stevens-Johnson Syndrome).
- The subject has a history of hypersensitivity to Chlorhexidine Gluconate (CHG) or Polyhexamethylene Biguanide (PHMB).
- The subject has severe systemic infection characterized by the systemic inflammatory response syndrome.
- The subject has taken part in a wound healing study within the past month.
- The subject has suspected or confirmed underlying osteomyelitis contiguous to the ulcer and is not receiving systemic antimicrobial therapy.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, M5S 1B2
About this study
Official title: A Prospective Randomized Double-Blind Trial of a Polyhexamethylene Biguanide (PHMB) Impregnated Gauze Dressing for the Prevention of Chronic Wound Colonization With Resistant and Prevalent Microorganisms
The purpose of this study is to determine if a new antimicrobial gauze dressing is better than the current method of dressing open wounds with plain sterile gauze. It is hoped that the antimicrobial gauze will reduce the number of germs in the open wound and even improve the rate of healing.
Read the detailed description
Without adequate debridement, chronically infected wounds persist and form a nidus for the acquisition of antimicrobial-resistant microorganisms. Multiple studies state that patients with chronic wounds were colonized with one or more resistant bacteria, and that the presence of a chronic wound or decubitus ulcer was associated with a statistically increased likelihood of colonization with methicillin-resistant Staphylococcus aureus (MRSA), ciprofloxacin-resistant gram-negative bacilli (GNB),colonization and infection with ceftazidime-resistant Escherichia coli and Klebsiella pneumoniae.
Recently, a newly formulated gauze dressing impregnated with an antiseptic agent has become available. This product offers the promise of a combined benefit of wet-to-dry mechanical debridement, while providing high local concentrations of a potent antiseptic to prevent colonization and infection of the wound by resistant microorganisms, potentially enhancing wound healing.
This study proposes to determine if use of the antimicrobial gauze in routine wound care results in a lower rate of chronic wound colonization with resistant microorganisms and prevalent microorganisms as compared to standard wound care (with non-antimicrobial gauze).
- Conditions
- Wounds
- Being tested
- KERLIX A.M.D. Gauze
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KERLIX A.M.D. GauzeDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of chronic wound colonization with resistant/prevalent microorganisms.
Secondary outcomes (1)
Rate of wound surface area healing over time; Antibiotic utilization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2005
- Study completionAug 2007
Why it stopped: Reallocation of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tyco Healthcare Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tonya M. Eggleston, RN, MPH, Study director, Tyco Healthcare/Kendall
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203489
- Sponsor's protocol ID
- Study Protocol 331.18
- Status last verified
- Nov 2007
- First submitted
- 12 Sep 2005
- Last updated
- 19 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Double-Blind Trial of a Polyhexamethylene Biguanide (PHMB) Impregnated Gauze Dressing for the Prevention of Chronic Wound Colonization With Resistant and Prevalent Microorganisms
- ClinicalTrials.gov ID
- NCT00203489
- Acronym / sponsor ID
- Study Protocol 331.18
- Conditions
- Wounds
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reallocation of funding.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tyco Healthcare GroupIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Study completion
- Aug 2007
- First posted
- 20 Sep 2005 (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 if a new antimicrobial gauze dressing is better than the current method of dressing open wounds with plain sterile gauze. It is hoped that the antimicrobial gauze will reduce the number of germs in the open wound and even improve the rate of healing.
Detailed description
Without adequate debridement, chronically infected wounds persist and form a nidus for the acquisition of antimicrobial-resistant microorganisms. Multiple studies state that patients with chronic wounds were colonized with one or more resistant bacteria, and that the presence of a chronic wound or decubitus ulcer was associated with a statistically increased likelihood of colonization with methicillin-resistant Staphylococcus aureus (MRSA), ciprofloxacin-resistant gram-negative bacilli (GNB),colonization and infection with ceftazidime-resistant Escherichia coli and Klebsiella pneumoniae.
Recently, a newly formulated gauze dressing impregnated with an antiseptic agent has become available. This product offers the promise of a combined benefit of wet-to-dry mechanical debridement, while providing high local concentrations of a potent antiseptic to prevent colonization and infection of the wound by resistant microorganisms, potentially enhancing wound healing.
This study proposes to determine if use of the antimicrobial gauze in routine wound care results in a lower rate of chronic wound colonization with resistant microorganisms and prevalent microorganisms as compared to standard wound care (with non-antimicrobial gauze).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject is receiving care at the study wound care clinics.
- The subject is 18 years of age or older.
- The subject or authorized representative has signed the Informed Consent form.
- The subject has a chronic wound as a result of pressure ulceration (grade III and IV ulcers only), underlying vascular disease ("leg ulcer"), diabetes mellitus (grade 2 and 3 ulcers only), or recent surgery.
Key exclusion criteria (11 listed)
- The subject has a chronic ulcer that is a result of a condition other than that defined in the inclusion criteria.
- The subject has stage I and II pressure ulceration.
- The subject has a superficial (grade 0 or 1) or limb-threatening diabetic foot ulceration (grade 4 or 5).
- The subject has a leg ulcer related to carcinoma.
- The subject is scheduled to go for amputation or surgical flap procedure as a result of an open 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 A.M.D. Gauze | Device | – |
Primary outcome
Rate of chronic wound colonization with resistant/prevalent microorganisms.
1 secondary outcome
Rate of wound surface area healing over time; Antibiotic utilization.
Results and safety
The study was stopped early (reason given: Reallocation of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2007.
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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.
Tonya M. Eggleston, RN, MPH study director
Tyco Healthcare/Kendall
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 A.M.D. Gauze in people with Wounds, run by Tyco Healthcare Group at 1 site in Canada.
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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 19 Nov 2007. 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 Canada. 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 was stopped early (reason given: Reallocation of funding.). Results are not available in the source record.
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?
Rate of chronic wound colonization with resistant/prevalent microorganisms.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2007.