CHG Dressings in Children With Central Lines

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: Terminated
• Conditions: Children With Central Venous Access
• Intervention / Treatment: Other: Tegaderm CHG clear dressing; Other: Standard clear Tegaderm dressing

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: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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

Outcome Measure	Measure Description	Time Frame
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.	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.	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

• Sponsor: Yale University
• Investigators: Principal Investigator: John S Giuliano Jr, MD, Yale University

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: September 27, 2013
• First Posted (Estimate): October 7, 2013

Study Record Updates

• Last Update Posted (Estimate): May 13, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Giuliano913