Children With Central Venous AccessNCT01955226
CHG Dressings in Children With Central Lines
A study testing Tegaderm CHG clear dressing and Standard clear Tegaderm dressing in people with Children With Central Venous Access, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Tegaderm CHG clear dressing reduces the number of unscheduled central catheter dressing changes compared to standard clear Tegaderm IV dressing in pediatric patients between the ages of 2 months to 18 years with central venous access. Read more about this study
- Who is it for?
- Ages 2 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Children With Central Venous Access
- What is being tested?
- Tegaderm CHG clear dressing and Standard clear Tegaderm dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to May 2016
- 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 2 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All patients 2 months to 18 years of age admitted with a central venous catheter expected to be in place for > 48 hours.
Who cannot join
- Patients with known allergies to chlorhexidine or Tegaderm and those previously enrolled in this study will be excluded.
- Patients with portacatheters
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unit Based Comparison of Non- Versus Chlorhexidine-Impregnated Central Line Dressings
The purpose of this study is to determine whether Tegaderm CHG clear dressing reduces the number of unscheduled central catheter dressing changes compared to standard clear Tegaderm IV dressing in pediatric patients between the ages of 2 months to 18 years with central venous access. Secondarily, we will monitor contact skin irritation and central line associated blood stream infections.
Read the detailed description
In this prospective, randomized, cohort study, we plan on enrolling all patients 2 months to 18 years of age admitted with a central venous catheter expected to be in place for > 48 hours. Patients will be randomized to either receive 1) Tegaderm CHG clear dressing or 2) standard clear Tegaderm IV dressing. All central line care will remain uniform between the two groups as dictated by the central line maintenance bundle currently directing central line care in our children's hospital. Study completion will occur at the time of central line removal or discharge from the hospital, whichever comes first.
- Conditions
- Children With Central Venous Access
- Being tested
- Tegaderm CHG clear dressing, Standard clear Tegaderm dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegaderm CHG clear dressingOther
Tegaderm CHG clear dressing will be used in central line care and will remain uniform as dictated by the central line maintenance bundle currently directing central line care in our children's hospital.
Standard clear Tegaderm dressingOther
Standard clear Tegaderm dressing will be used in central line care and will remain uniform as dictated by the central line maintenance bundle currently directing central line care in our children's hospital.
| Study group | Role | What they receive |
|---|---|---|
| Tegaderm CHG clear dressing | Experimental | Patients randomized to receive Tegaderm CHG clear dressing. All central line care will remain uniform between the two groups as dictated by the central line maintenance bundle currently directing central line care in our children's hospital. Receives: Other: Tegaderm CHG clear dressing |
| Standard clear Tegaderm dressing | Active comparator | Patients randomized to receive standard clear Tegaderm dressing. All central line care will remain uniform between the two groups as dictated by the central line maintenance bundle currently directing central line care in our children's hospital. Receives: Other: Standard clear Tegaderm dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in unscheduled central catheter dressing changes
The policy at our institution is to change central catheter dressings every 7 days unless they are soiled or detached. We will document dressing changes for the duration of line use and document the reason for the dressing change.
Measured: Study completion (Study completion will occur at the time of central line removal or discharge from the hospital, whichever comes first). On average 2 weeks.
Secondary outcomes (2)
Blood Stream Infection
Blood stream infections will be tallied and reported per 1,000 central line days. Infection is attributed to the line if a culture becomes positive when the line is in up to 48 hours after removal.
Measured: Discharge (at 2 weeks or more)
Skin irritation
Skin irritation will be assessed using the Scoring of patch tests according to the International Contact Dermatitis Research Group. Scores of 0 are defined as no irritation, 1/2-1+ as minor irritation whereas scores greater than or equal to 2+ will be classified as severe and will require dressing removal.
The clinical team will photograph each central line insertion site with every dressing change and save the most severe skin irritation photo for analysis. These pictures will be sequentially numbered and a master list will link them to each patient.
Measured: Study completion (Study completion will occur at the time of central line removal or discharge from the hospital, whichever comes first). On average 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startFeb 2014
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Central Venous AccessStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John S Giuliano Jr, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955226
- Sponsor's protocol ID
- Giuliano913
- Status last verified
- May 2016
- First submitted
- 24 Sep 2013
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unit Based Comparison of Non- Versus Chlorhexidine-Impregnated Central Line Dressings
- ClinicalTrials.gov ID
- NCT01955226
- Acronym / sponsor ID
- Giuliano913
- Conditions
- Children With Central Venous Access
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 Oct 2013 (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 Tegaderm CHG clear dressing reduces the number of unscheduled central catheter dressing changes compared to standard clear Tegaderm IV dressing in pediatric patients between the ages of 2 months to 18 years with central venous access. Secondarily, we will monitor contact skin irritation and central line associated blood stream infections.
Detailed description
In this prospective, randomized, cohort study, we plan on enrolling all patients 2 months to 18 years of age admitted with a central venous catheter expected to be in place for > 48 hours. Patients will be randomized to either receive 1) Tegaderm CHG clear dressing or 2) standard clear Tegaderm IV dressing. All central line care will remain uniform between the two groups as dictated by the central line maintenance bundle currently directing central line care in our children's hospital. Study completion will occur at the time of central line removal or discharge from the hospital, whichever comes first.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tegaderm CHG clear dressing | Experimental | Other: Tegaderm CHG clear dressingPatients randomized to receive Tegaderm CHG clear dressing. All central line care will remain uniform between the two groups as dictated by the central line maintenance bundle currently directing central line care in our children's hospital. |
| Standard clear Tegaderm dressing | Active comparator | Other: Standard clear Tegaderm dressingPatients randomized to receive standard clear Tegaderm dressing. All central line care will remain uniform between the two groups as dictated by the central line maintenance bundle currently directing central line care in our children's hospital. |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients 2 months to 18 years of age admitted with a central venous catheter expected to be in place for > 48 hours.
Key exclusion criteria (2 listed)
- Patients with known allergies to chlorhexidine or Tegaderm and those previously enrolled in this study will be excluded.
- Patients with portacatheters
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 |
|---|---|---|
| Tegaderm CHG clear dressingTegaderm CHG clear dressing will be used in central line care and will remain uniform as dictated by the central line maintenance bundle currently directing central line care in our children's hospital. | Other | Tegaderm CHG clear dressing |
| Standard clear Tegaderm dressingStandard clear Tegaderm dressing will be used in central line care and will remain uniform as dictated by the central line maintenance bundle currently directing central line care in our children's hospital. | Other | Standard clear Tegaderm dressing |
Primary outcome
Reduction in unscheduled central catheter dressing changes
Time frame: Study completion (Study completion will occur at the time of central line removal or discharge from the hospital, whichever comes first). On average 2 weeks.
The policy at our institution is to change central catheter dressings every 7 days unless they are soiled or detached. We will document dressing changes for the duration of line use and document the reason for the dressing change.
2 secondary outcomes
Blood Stream Infection
Time frame: Discharge (at 2 weeks or more)
Skin irritation
Time frame: Study completion (Study completion will occur at the time of central line removal or discharge from the hospital, whichever comes first). On average 2 weeks.
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
Related trials for Children With Central Venous Access
Recruiting
Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia
Virtual Reality, Children and Adolescents
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.
John S Giuliano Jr, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tegaderm CHG clear dressing and Standard clear Tegaderm dressing in people with Children With Central Venous Access, run by Yale University 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 2 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 13 May 2016. 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: Poor enrollment). 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?
Reduction in unscheduled central catheter dressing changes (time frame: Study completion (Study completion will occur at the time of central line removal or discharge from the hospital, whichever comes first). On average 2 weeks.). 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 13 May 2016.