CatheterizationPhase 2/3NCT00516906

Clinical Performance of a Chlorhexidine Antimicrobial Dressing

A Phase 2/3 study testing Chlorhexidine gluconate and Transparent Adhesive Dressing in people with Catheterization, run by Solventum US LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Evaluate the clinical performance of a new IV Dressing in Comparison to a standard IV Dressing Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Catheterization
What is being tested?: Chlorhexidine gluconate and Transparent Adhesive Dressing
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: No sites listed yet
Study dates: Oct 2007to Jan 2008
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Males or Females over 18 years of age
Patients with an existing, or newly inserted, central venous catheter
Patients who require the catheter for at least 3 days

Who cannot join

Sensitivity to chlorhexidine

About this study

Evaluate the clinical performance of a new IV Dressing in Comparison to a standard IV Dressing

Read the detailed description

Prospective, controlled, randomized, clinical trial comparing the 3M™ TegadermTM CHG (Chlorhexidine Gluconate) IV Securement Dressing (3M Healthcare, St Paul, MN) to a standard transparent dressing.

Conditions: Catheterization
Being tested: Chlorhexidine gluconate, Transparent Adhesive Dressing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chlorhexidine gluconateDrug
Also called 3M(TM) Tegaderm(TM) CHG Dressing
2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear
Transparent Adhesive DressingDrug
Also called TAD, Polyurethane Dressing, Transparent Membrane Dressing
Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear

Study groups in NCT00516906
Study group	Role	What they receive
Transparent Adhesive Dressing	Placebo comparator	Standard of Care Non-Antimicrobial Transparent Adhesive Dressing Receives: Drug: Transparent Adhesive Dressing
CHG antimicrobial transparent dressing	Experimental	Chlorhexidine gluconate antimicrobial transparent adhesive dressing Receives: Drug: Chlorhexidine gluconate

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinician Overall Satisfaction With Catheter Securement
Clinician Overall Satisfaction with Catheter Securement Five Point Scale: 1 = Very Good, 5= Very Poor
Measured: Daily up to 7 Days (average 3-7 days of wear)

Secondary outcomes (2)

Clinician Overall Satisfaction With Dressing
Clinician Overall Satisfaction with Dressing Five point scale: 1= Very Good, 5= Very poor
Measured: Daily up to 7 Days (average 3-7 days of wear)
Rating of Skin Condition
Ratings of skin condition for erythema on a 0 to 3 scale (0 = None, 1=Mild, 2=Moderate, 3=Severe)
Measured: Daily up to 7 Days (average 3-7 days of wear)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Jan 2008

First posted16 Aug 2007 (estimated)
Study startOct 2007
Primary completionDec 2007
Study completionJan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CatheterizationStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00516906
Sponsor's protocol ID: 05-010691
Status last verified: Sep 2024
First submitted: 14 Aug 2007
Last updated: 24 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Catheterization trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Performance of a Chlorhexidine Antimicrobial Dressing
ClinicalTrials.gov ID: NCT00516906
Acronym / sponsor ID: 05-010691
Conditions: Catheterization
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Solventum US LLCIndustry (pharma, biotech, devices)
Collaborators: University of Nebraska, 3M
Study start: Oct 2007
Primary completion: Dec 2007 (actual)
Study completion: Jan 2008 (actual)
First posted: 16 Aug 2007 (estimated)
Results: Posted 23 Feb 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluate the clinical performance of a new IV Dressing in Comparison to a standard IV Dressing

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Transparent Adhesive Dressing	Placebo comparator	Drug: Transparent Adhesive DressingStandard of Care Non-Antimicrobial Transparent Adhesive Dressing
CHG antimicrobial transparent dressing	Experimental	Drug: Chlorhexidine gluconateChlorhexidine gluconate antimicrobial transparent adhesive dressing

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Males or Females over 18 years of age
Patients with an existing, or newly inserted, central venous catheter
Patients who require the catheter for at least 3 days

Key exclusion criteria (1 listed)

Sensitivity to chlorhexidine

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
Chlorhexidine gluconateAlso: 3M(TM) Tegaderm(TM) CHG Dressing2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear	Drug	CHG antimicrobial transparent dressing
Transparent Adhesive DressingAlso: TAD, Polyurethane Dressing, Transparent Membrane DressingStandard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear	Drug	Transparent Adhesive Dressing

Primary outcome

Clinician Overall Satisfaction With Catheter Securement
Time frame: Daily up to 7 Days (average 3-7 days of wear)
Clinician Overall Satisfaction with Catheter Securement Five Point Scale: 1 = Very Good, 5= Very Poor

2 secondary outcomes

Clinician Overall Satisfaction With Dressing
Time frame: Daily up to 7 Days (average 3-7 days of wear)
Rating of Skin Condition
Time frame: Daily up to 7 Days (average 3-7 days of wear)

Results and safety

Results posted to the registry on 23 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Comparator: A	36	30
CHG Antimicrobial Transparent Dressing	32	30

Primary outcome: Clinician Overall Satisfaction With Catheter Securement

Time frame: Daily up to 7 Days (average 3-7 days of wear). Mean (Standard Deviation). Unit: Units on a scale

Measure	Placebo Comparator: A n = 30	CHG Antimicrobial Transparent Dressing n = 30
Value	2.27 (0.78)	1.63 (1.63)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study ran 3 months (10 October 2008- 20 December 2008) The maximum length of exposure of each patient to the dressings was 7.1 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Comparator: A	1 of 30 (3.3%)	2 of 30 (6.7%)	Not reported
CHG Antimicrobial Transparent Dressing	3 of 30 (10%)	2 of 30 (6.7%)	Not reported

Limitations and caveats (from the sponsor): This trial evaluated the dressing for it's securement and ease of use adaption into healthcare practices compared to a standard transparent dressing. The sample size was too small to evaluate any effect on Catheter Related-Bloodstream Infection.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
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Not yet recruiting
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RecruitingPhase 4
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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.

Mark E Rupp, M.D. principal investigator

Nebraska Medical Center

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Chlorhexidine gluconate and Transparent Adhesive Dressing in people with Catheterization, run by Solventum US LLC.

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 3 inclusion and 1 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 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clinician Overall Satisfaction With Catheter Securement (time frame: Daily up to 7 Days (average 3-7 days of wear)). 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 NCT00516906.

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 24 Oct 2024.