Parafilm to Prevent CLABSI in Pediatric Patients Undergoing HCT

Emory University

Status: Completed

Conditions: Bone Marrow Transplant; Central Line Associated Bloodstream Infections (CLABSI)

Treatments: Device: Parafilm

Study type: Interventional

Funder types: Other

Identifiers

NCT02575079

IRB00080344

Details and patient eligibility

About

The purpose of this study is to see if applying parafilm as an external barrier on the central line in children having a bone marrow transplant helps to prevent central line associated bloodstream infection(s) and also to assess the ease of use of parafilm.

Full description

Central line associated bloodstream infections (CLABSI) result in significant morbidity and mortality, particularly in patients undergoing hematopoietic cell transplantation (HCT). HCT patients are at high risk for CLABSI due to multiple factors, including prolonged immune suppression and the need for long-term central venous access. The investigators want to assess the feasibility of the use of a parafilm central line barrier (parafilm) as standard of care in pediatric HCT patients. The investigators will also assess the effectiveness of the parafilm to reduce the incidence of CLABSI in these patients.

Enrollment: 119 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be between the age of 0 and 21 years at the time of enrollment
• Must be undergoing allogeneic or autologous HCT for a malignant or non-malignant disorder
• Must have or be scheduled to have a tunneled CVC

Exclusion criteria

• Patients undergoing other interventions to prevent CLABSI (e.g. Children's Oncology Group (COG) study ACCL1034 with Chlorhexidine Gluconate (CHG); antimicrobial lock therapy, etc.)
• Patients who only have a port

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

Parafilm

Experimental group

Description:

Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) will have pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected). Parafilm will be maintained on the CVC and routine CVC care will be continued, per institutional standard of practice, until the CVC is removed.

Treatment:

Device: Parafilm

Historical Cohort

No Intervention group

Description:

Pediatric patients receiving hematopoietic cell transplantation in the 16 months preceding the study intervention. Data were obtained retrospectively through medical records for the purpose of comparing CLABSI rates among recipients of parafilm to a control group.