Parafilm to Prevent CLABSI in Pediatric Patients Undergoing HCT

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-03-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Central Line Associated Bloodstream Infections (CLABSI) Bone Marrow Transplant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Arm 1 is comprised of study participants receiving parafilm applied over the CVC hub or around the CVC hub connection. Arm 2 is a retrospective historical cohort of pediatric patients receiving HCT for the purpose of comparing CLABSI rates.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Parafilm

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.

Group Type EXPERIMENTAL

Parafilm

Intervention Type DEVICE

Single-use, pre-cut sections of parafilm over the central venous catheter (CVC) hub (if not connected) or around the CVC hub connection (if connected). Parafilm will be maintained on the CVC until it is removed.

Historical Cohort

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Parafilm

Single-use, pre-cut sections of parafilm over the central venous catheter (CVC) hub (if not connected) or around the CVC hub connection (if connected). Parafilm will be maintained on the CVC until it is removed.

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No