Surgical Wound InfectionNCT00203541
Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections
A study testing TELFA™ A.M.D. Island dressing in people with Surgical Wound Infection, run by Tyco Healthcare Group at 1 site in United States.
Trial summary
The primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative incidence rate(CI) of localized, superficial infections at the sternal incisional site as compared to the control group… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- TELFA™ A.M.D. Island dressing
- Type of treatment
- Medical device
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Jun 2006
- 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
- Adult, Older adult
Who may be able to join
- Sign an informed consent form that has been approved by the Institutional Review Board.
- Adults at least 18 years of age.
- Be undergoing cardiopulmonary bypass surgery with a median sternotomy.
- Be able to return to the study site, if needed, to have the sternal surgical incision site inspected.
Who cannot join
- Be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Be in need of a left ventricular assist device.
- Have an active pre-operative infectious process.
- Subject is to receive another topical antimicrobial agent (i.e., Dermabond® Topical Skin Adhesive) other than the study dressing (as assigned by the randomization schedule).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections in Subjects Who Have Undergone Cardiac Surgical Procedures Requiring Median Sternotomy
The primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative incidence rate(CI) of localized, superficial infections at the sternal incisional site as compared to the control group, regular, non-antimicrobial dressing.
- Conditions
- Surgical Wound Infection
- Being tested
- TELFA™ A.M.D. Island dressing
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TELFA™ A.M.D. Island dressingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased cumulative incidence rate of superficial surgical site infections localized at the sternal incision in the treatment group as compared to the control group.
Secondary outcomes (1)
Reduction of microbial log counts at the incisional site in the treatment group compared to the control group; Decreased cumulative incidence of mediastinitis in the treatment group as compared to the control group
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 startFeb 2004
- Study completionJun 2006
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 Surgical Wound InfectionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,100 participants
Sponsor and investigators
- Lead sponsor
- Tyco Healthcare Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Katie Kavounis, MPH, Study director, Tyco Healthcare/Kendall
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203541
- Sponsor's protocol ID
- 301.18
- 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
- Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections in Subjects Who Have Undergone Cardiac Surgical Procedures Requiring Median Sternotomy
- ClinicalTrials.gov ID
- NCT00203541
- Acronym / sponsor ID
- 301.18
- Conditions
- Surgical Wound Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reallocation of funding.
- Enrolment
- 1,100 participants
- Lead sponsor
- Tyco Healthcare GroupIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Jun 2006
- 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 primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative incidence rate(CI) of localized, superficial infections at the sternal incisional site as compared to the control group, regular, non-antimicrobial dressing.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sign an informed consent form that has been approved by the Institutional Review Board.
- Adults at least 18 years of age.
- Be undergoing cardiopulmonary bypass surgery with a median sternotomy.
- Be able to return to the study site, if needed, to have the sternal surgical incision site inspected.
Key exclusion criteria (4 listed)
- Be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Be in need of a left ventricular assist device.
- Have an active pre-operative infectious process.
- Subject is to receive another topical antimicrobial agent (i.e., Dermabond® Topical Skin Adhesive) other than the study dressing (as assigned by the randomization schedule).
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 |
|---|---|---|
| TELFA™ A.M.D. Island dressing | Device | – |
Primary outcome
Decreased cumulative incidence rate of superficial surgical site infections localized at the sternal incision in the treatment group as compared to the control group.
1 secondary outcome
Reduction of microbial log counts at the incisional site in the treatment group compared to the control group; Decreased cumulative incidence of mediastinitis in the treatment group as compared to the control group
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.
Katie Kavounis, 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 TELFA™ A.M.D. Island dressing in people with Surgical Wound Infection, run by Tyco Healthcare Group 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 4 inclusion and 4 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 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 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?
Decreased cumulative incidence rate of superficial surgical site infections localized at the sternal incision in the treatment group as compared to the control group.. 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.