CHG Dressings in Children With Central Lines

May 11, 2016 updated by: Yale University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients 2 months to 18 years of age admitted with a central venous catheter expected to be in place for > 48 hours.

Exclusion Criteria:

  • Patients with known allergies to chlorhexidine or Tegaderm and those previously enrolled in this study will be excluded.
  • Patients with portacatheters

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tegaderm CHG clear dressing
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.
Other: Tegaderm CHG clear dressing
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.
Active Comparator: Standard clear Tegaderm dressing
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.
Other: Standard clear Tegaderm dressing
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Stream Infection
Time Frame: Discharge (at 2 weeks or more)
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.
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.

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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John S Giuliano Jr, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Giuliano913

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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