## Protocol Section
### Identification Module
**NCT ID:** NCT02575079

**Brief Title:** Parafilm to Prevent CLABSI in Pediatric Patients Undergoing HCT

**Official Title:** Parafilm Application to Prevent Central Line Associated Bloodstream Infections in Pediatric Patients Undergoing Hematopoietic Cell Transplantation

#### Organization Study ID Info
**ID:** IRB00080344
#### Organization
**Class:** OTHER
**Full Name:** Emory University
### Status Module
#### Completion Date
**Date:** 2018-03-29

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-06-25

**Type:** ACTUAL

**Last Update Submit Date:** 2019-06-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-03-29

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-06-25

**Type:** ACTUAL

**Results First Submit Date:** 2019-03-29

**Results First Submit QC Date:** 2019-06-06

#### Start Date
**Date:** 2015-03

**Status Verified Date:** 2019-06

#### Study First Post Date
**Date:** 2015-10-14
**Type:** ESTIMATED
**Study First Submit Date:** 2015-10-12
**Study First Submit QC Date:** 2015-10-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Emory University

#### Responsible Party

**Investigator Affiliation:** Emory University

**Investigator Full Name:** Lakshmanan Krishnamurti

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Central Line Associated Bloodstream Infections (CLABSI)

- Bone Marrow Transplant

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 119

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Device: Parafilm

**Label:** Parafilm

**Type:** EXPERIMENTAL

#### Arm Group 2

**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.

**Label:** Historical Cohort

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Parafilm

**Description:** 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.

**Name:** Parafilm

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Central line associated bloodstream infections (CLABSI) is the identification of a bacterial infection from a blood culture drawn from a central venous catheter (CVC) in the absence of a primary source of infection from another body site. The CLABSI rate (total number of CLABSI/1000 catheter-days) in parafilm study participants will be calculated and compared to the CLABSI rate in a historical cohort of pediatric patients who are serving as a control group.

**Measure:** Rate of Central Line Associated Bloodstream Infections (CLABSI)

**Time Frame:** Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)

**Description:** In the inpatient setting, compliance was measured by once daily recording of parafilm change by nursing in the electronic medical record. These data were significantly limited by electronic medical record charting on parafilm change being required only once per day. Thus, once daily data collection failed to capture daily parafilm change, given multiple nursing shifts on a single calendar day. Nonetheless, the percentage of catheter-days with intact correctly applied parafilm, as reported by nursing staff, was calculated.

**Measure:** Reported Inpatient Percentage of Central-line Days With Correctly Applied Parafilm

**Time Frame:** At discharge (an expected average of 6 weeks from admission)

**Description:** Observed compliance occurred during weekly line rounds. Rounding providers indicated whether a patient's parafilm is intact and correctly applied, not applied, or incorrectly applied or not intact. The percentage of "observed catheter-days" where patients had correct use of intact parafilm were to be calculated. To track observed inpatient compliance with applying parafilm, data fields were added to the entered to the nursing charts of the participant's electronic medical record (EMR). The primary field added was a no/question about parafilm applied. Per study protocol, the intent was to document nursing changing of the parafilm, at the time it was changed. However, on reviewing the data, it appears that nursing just charted once per day whether they had changed parafilm or not, while the parafilm may have been changed earlier by a different nurse.

**Measure:** Observed Inpatient Percentage of Catheter-days With Correctly Applied Parafilm

**Time Frame:** Time between initial bone marrow transplant (BMT) discharge and either central venous line (CVL) removal or transfer back to primary MD (an expected average of 2-3 months)

**Description:** For outpatient reported compliance, parents of study participants provided their logs to outpatient staff who documented the number of days parafilm was correctly in use/intact vs not in use or incorrectly in use/not intact. The cumulative percentage of catheter-days where parafilm was intact was calculated.

**Measure:** Reported Outpatient Percentage of Catheter-days With Correctly Applied Parafilm

**Time Frame:** Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)

**Description:** For observed compliance, the outpatient nurse recorded whether the patient's parafilm was correctly applied/intact (yes), not applied (no), or incorrectly applied/not intact (yes-inc) at the beginning of the visit. The percentage of outpatient "observed catheter-days" where parafilm was correctly in use/intact was calculated.

**Measure:** Observed Outpatient Percentage of Catheter-days With Correctly Applied Parafilm

**Time Frame:** Time between initial BMT discharge and either CVL removal or transfer back to primary MD (an expected average of 2-3 months)

#### Secondary Outcomes

**Description:** The number of antibiotic treatment courses per participant in the parafilm study will be recorded.

**Measure:** Number of Antibiotic Treatment Courses Per Participant

**Time Frame:** Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)

**Description:** Total duration of antibiotic treatment exposure (excluding prophylactic antibiotics) among participants in the parafilm study will be reported.

**Measure:** Duration of Antibiotic Treatment Exposure

**Time Frame:** Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)

**Description:** The cumulative number of ICU admissions secondary to sepsis among participants in the parafilm study is reported.

**Measure:** Number of ICU Admissions Secondary to Sepsis

**Time Frame:** Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)

**Description:** Deaths from infection and death from any cause among participants in the parafilm study are reported.

**Measure:** Death

**Time Frame:** Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)

**Description:** The perception of parafilm from provider and caregiver surveys regarding parafilm ease of use, perceived benefit, and other parameters will be reported

**Measure:** Perception of Parafilm

**Time Frame:** Month 3 (average time till removal of CVC)

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Atlanta

**Country:** United States

**Facility:** Children's Healthcare of Atlanta

**State:** Georgia

**Zip:** 30322

#### Overall Officials

**Official 1:**

**Affiliation:** Emory University

**Name:** Lakshmanan Krishnamurti, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Stenger EO, Newton JG, Leong T, Kendrick L, McManus L, Rooke C, Krishnamurti L. Application of parafilm as a physical barrier on CVC connections is feasible and may reduce CLABSI among pediatric HCT patients. Biology of Blood Marrow Transplantation 25 (Suppl 3): S131, 2019.

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-10-24

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 271677

- Type Abbrev: Prot_SAP

- Upload Date: 2019-03-18T09:44

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000018746

- Term: Systemic Inflammatory Response Syndrome

- ID: D000007249

- Term: Inflammation

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20864

- Name: Sepsis

- Relevance: HIGH

- As Found: Bloodstream Infection

- ID: M16869

- Name: Toxemia

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M20818

- Name: Systemic Inflammatory Response Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000018805

- Term: Sepsis

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Adverse events will be described using event terms and severity grading from the National Cancer Institute (NCI) CTCAE version 4.0. Adverse events will be characterized by severity grading, attribution (relationship to study treatment), and expectedness (based upon prior experience). Only unexpected serious adverse events and serious adverse events related to the study intervention were collected. Non-serious adverse events were not collected.

#### Event Groups

**Group ID:** EG000

**Title:** Parafilm

**Deaths Num Affected:** 3

**Deaths Num At Risk:** 48

**Description:** Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).

**ID:** EG000

**Serious Number Affected:** 3

**Serious Number At Risk:** 48

**Title:** Parafilm

**Frequency Threshold:** 0

#### Serious Events

**Term:** Acute hypoxemic respiratory failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 48

**Num Events:** 1

**Term:** Graft versus host disease (GVHD)

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 48

**Num Events:** 2

**Time Frame:** Adverse events were collected from the time a participant entered the study until CVC removal (3 months on average).

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 48

**Group ID:** BG001

**Value:** 71

**Group ID:** BG002

**Value:** 119

**Units:** Participants

### Group

**ID:** BG000

**Title:** Parafilm

**Description:** Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).

### Group

**ID:** BG001

**Title:** Historical Cohort

**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.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 21

#### Measurement

**Group ID:** BG002

**Value:** 28

**Category Title:** Less than or equal to 2 years

#### Measurement

**Group ID:** BG000

**Value:** 25

#### Measurement

**Group ID:** BG001

**Value:** 22

#### Measurement

**Group ID:** BG002

**Value:** 47

**Category Title:** Between 3 and 9 years

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 28

#### Measurement

**Group ID:** BG002

**Value:** 44

**Category Title:** Between 10 and 21 years

**Class Title:** Age in years

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 17

#### Measurement

**Group ID:** BG001

**Value:** 25

#### Measurement

**Group ID:** BG002

**Value:** 42

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 31

#### Measurement

**Group ID:** BG001

**Value:** 46

#### Measurement

**Group ID:** BG002

**Value:** 77

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 14

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 40

#### Measurement

**Group ID:** BG001

**Value:** 65

#### Measurement

**Group ID:** BG002

**Value:** 105

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 21

#### Measurement

**Group ID:** BG001

**Value:** 32

#### Measurement

**Group ID:** BG002

**Value:** 53

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 25

#### Measurement

**Group ID:** BG001

**Value:** 34

#### Measurement

**Group ID:** BG002

**Value:** 59

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Other

**Class Title:** Ethnicity

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 48

#### Measurement

**Group ID:** BG001

**Value:** 71

#### Measurement

**Group ID:** BG002

**Value:** 119

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 35

#### Measurement

**Group ID:** BG001

**Value:** 49

#### Measurement

**Group ID:** BG002

**Value:** 84

**Category Title:** Allogeneic

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 22

#### Measurement

**Group ID:** BG002

**Value:** 35

**Category Title:** Autologous

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 17

#### Measurement

**Group ID:** BG001

**Value:** 24

#### Measurement

**Group ID:** BG002

**Value:** 41

**Category Title:** Malignant, hematologic

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 21

#### Measurement

**Group ID:** BG002

**Value:** 33

**Category Title:** Malignant, solid tumor

#### Measurement

**Group ID:** BG000

**Value:** 19

#### Measurement

**Group ID:** BG001

**Value:** 26

#### Measurement

**Group ID:** BG002

**Value:** 45

**Category Title:** Non-malignant

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 6
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Type of HCT
**Unit of Measure:** Participants
### Measure 7
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Underlying disease
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Limitations and Caveats
**Description:** Assessing feasibility of outpatient parafilm use was limited by difficulty collecting parafilm compliance calendars from caretakers and observed variability of compliance in the outpatient setting.
### Point of Contact
**Email:** elizabeth.o'brien.stenger@emory.edu
**Organization:** Emory University
**Phone:** 404-785-1272
**Title:** Elizabeth Stenger
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.19
- **Spread:** 
- **Upper Limit:** 5.83
- **Value:** 3.69
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.86
- **Spread:** 
- **Upper Limit:** 6.40
- **Value:** 4.37
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 65.2
**Title:** 
#### Outcome Measure 3
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 64.7
**Title:** 
#### Outcome Measure 5
#### Outcome Measure 6
#### Outcome Measure 7
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 10
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Central line associated bloodstream infections (CLABSI) is the identification of a bacterial infection from a blood culture drawn from a central venous catheter (CVC) in the absence of a primary source of infection from another body site. The CLABSI rate (total number of CLABSI/1000 catheter-days) in parafilm study participants will be calculated and compared to the CLABSI rate in a historical cohort of pediatric patients who are serving as a control group.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
**Title:** Rate of Central Line Associated Bloodstream Infections (CLABSI)
**Type:** PRIMARY
**Unit of Measure:** CLABSI/1000 catheter-days
##### Group
**Description:** Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
**ID:** OG000
**Title:** Parafilm
##### 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.
**ID:** OG001
**Title:** Historical Cohort
#### Outcome Measure 2
**Description:** In the inpatient setting, compliance was measured by once daily recording of parafilm change by nursing in the electronic medical record. These data were significantly limited by electronic medical record charting on parafilm change being required only once per day. Thus, once daily data collection failed to capture daily parafilm change, given multiple nursing shifts on a single calendar day. Nonetheless, the percentage of catheter-days with intact correctly applied parafilm, as reported by nursing staff, was calculated.
**Parameter Type:** NUMBER
**Population Description:** Participants in the parafilm study are included in this analysis. Percentage of inpatient days where nursing charted parafilm change in the electronic medical record is reported for the entire parafilm cohort.
**Reporting Status:** POSTED
**Time Frame:** At discharge (an expected average of 6 weeks from admission)
**Title:** Reported Inpatient Percentage of Central-line Days With Correctly Applied Parafilm
**Type:** PRIMARY
**Unit of Measure:** percentage of central-line days
##### Group
**Description:** Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
**ID:** OG000
**Title:** Parafilm
#### Outcome Measure 3
**Description:** Observed compliance occurred during weekly line rounds. Rounding providers indicated whether a patient's parafilm is intact and correctly applied, not applied, or incorrectly applied or not intact. The percentage of "observed catheter-days" where patients had correct use of intact parafilm were to be calculated. To track observed inpatient compliance with applying parafilm, data fields were added to the entered to the nursing charts of the participant's electronic medical record (EMR). The primary field added was a no/question about parafilm applied. Per study protocol, the intent was to document nursing changing of the parafilm, at the time it was changed. However, on reviewing the data, it appears that nursing just charted once per day whether they had changed parafilm or not, while the parafilm may have been changed earlier by a different nurse.
**Population Description:** The data collected indicated that nursing staff did not understand how the parafilm monitoring needed to be charted for the purposes of data analysis. Although a data field was created in the EMR, in practice, the data collected was not an accurate assessment of parafilm use, thus no data are available for analysis of this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Time between initial bone marrow transplant (BMT) discharge and either central venous line (CVL) removal or transfer back to primary MD (an expected average of 2-3 months)
**Title:** Observed Inpatient Percentage of Catheter-days With Correctly Applied Parafilm
**Type:** PRIMARY
##### Group
**Description:** Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
**ID:** OG000
**Title:** Parafilm
#### Outcome Measure 4
**Description:** For outpatient reported compliance, parents of study participants provided their logs to outpatient staff who documented the number of days parafilm was correctly in use/intact vs not in use or incorrectly in use/not intact. The cumulative percentage of catheter-days where parafilm was intact was calculated.
**Parameter Type:** NUMBER
**Population Description:** The population used for this analysis consists of caretakers who returned outpatient logs of parafilm use at the end of the study. Forty-one participants used parafilm in the outpatient setting and of these 34 returned the outpatient logs.
**Reporting Status:** POSTED
**Time Frame:** Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
**Title:** Reported Outpatient Percentage of Catheter-days With Correctly Applied Parafilm
**Type:** PRIMARY
**Unit of Measure:** percent of catheter-days
##### Group
**Description:** Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
**ID:** OG000
**Title:** Parafilm
#### Outcome Measure 5
**Description:** For observed compliance, the outpatient nurse recorded whether the patient's parafilm was correctly applied/intact (yes), not applied (no), or incorrectly applied/not intact (yes-inc) at the beginning of the visit. The percentage of outpatient "observed catheter-days" where parafilm was correctly in use/intact was calculated.
**Population Description:** Observed outpatient compliance was not performed as it was difficult to implement this in a busy clinic setting.
**Reporting Status:** POSTED
**Time Frame:** Time between initial BMT discharge and either CVL removal or transfer back to primary MD (an expected average of 2-3 months)
**Title:** Observed Outpatient Percentage of Catheter-days With Correctly Applied Parafilm
**Type:** PRIMARY
##### Group
**Description:** Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
**ID:** OG000
**Title:** Parafilm
#### Outcome Measure 6
**Description:** The number of antibiotic treatment courses per participant in the parafilm study will be recorded.
**Population Description:** Data on antibiotic treatment courses were not collected.
**Reporting Status:** POSTED
**Time Frame:** Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
**Title:** Number of Antibiotic Treatment Courses Per Participant
**Type:** SECONDARY
##### Group
**Description:** Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
**ID:** OG000
**Title:** Parafilm
#### Outcome Measure 7
**Description:** Total duration of antibiotic treatment exposure (excluding prophylactic antibiotics) among participants in the parafilm study will be reported.
**Population Description:** Data on duration of antibiotic treatments were not collected.
**Reporting Status:** POSTED
**Time Frame:** Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
**Title:** Duration of Antibiotic Treatment Exposure
**Type:** SECONDARY
##### Group
**Description:** Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
**ID:** OG000
**Title:** Parafilm
#### Outcome Measure 8
**Description:** The cumulative number of ICU admissions secondary to sepsis among participants in the parafilm study is reported.
**Parameter Type:** NUMBER
**Population Description:** Participants in the parafilm study are included in this analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
**Title:** Number of ICU Admissions Secondary to Sepsis
**Type:** SECONDARY
**Unit of Measure:** ICU admissions
##### Group
**Description:** Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
**ID:** OG000
**Title:** Parafilm
#### Outcome Measure 9
**Description:** Deaths from infection and death from any cause among participants in the parafilm study are reported.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Participants in the parafilm study are included in this analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
**Title:** Death
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
**ID:** OG000
**Title:** Parafilm
#### Outcome Measure 10
**Description:** The perception of parafilm from provider and caregiver surveys regarding parafilm ease of use, perceived benefit, and other parameters will be reported
**Population Description:** A survey was initially planned for in the protocol but was removed from the study procedures prior to any participants completing the survey.
**Reporting Status:** POSTED
**Time Frame:** Month 3 (average time till removal of CVC)
**Title:** Perception of Parafilm
**Type:** SECONDARY
##### Group
**Description:** Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
**ID:** OG000
**Title:** Parafilm
### Participant Flow Module
#### Group
**Description:** Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
**ID:** FG000
**Title:** Parafilm
#### 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.
**ID:** FG001
**Title:** Historical Cohort
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 48
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 71
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 42
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 71
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Pre-Assignment Details:** Fifty-one individuals consented to participate in the study. Prior to beginning any study interventions one was lost to follow up, one withdrew, and one did not begin the prep regimen, resulting in 48 participants who began the study intervention.
**Recruitment Details:** Participants were enrolled in the parafilm study between March 2015 and June 2017. All study procedures and follow up was completed on March 29, 2018.
**Has Results:** True