Trial Outcomes & Findings for Innovative Central Line Securement Device in the Pediatric Population (NCT NCT04522778)

NCT ID: NCT04522778

Last Updated: 2024-07-05

Results Overview

Number of line breaks defined as any mechanical trauma to the line that required repair but not replacement of the line.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: For a maximum of 1 year from enrollment
• Results posted on: 2024-07-05

Participant Flow

Participant milestones

Measure	Device Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Overall Study STARTED	12	11
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Device Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. They will continued to wear sterile dressing, the standard of care, underneath the device. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Overall Study Patient did not want to wear the device	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Device n=12 Participants After randomization and device securementall families filled out a baseline demographics form and a baseline QOL survey. Patients were then followed for 12 months from initial enrollment. At subsequent clinic visits patients and families filled out follow-up surveys detailing potential line related complications. They were also given the same QOL survey that they filled out at the time of initial enrollment. These follow-up surveys were administered between 3-6 times throughout the year. Subjects' charts were routinely reviewed over the study, monitoring for ER visits, hospital admissions and line related complications.	Traditional Securement Dressing n=11 Participants After randomization all families filled out a baseline demographics form and a baseline QOL survey. Patients were then followed for 12 months from initial enrollment. At subsequent clinic visits patients and families filled out follow-up surveys detailing potential line related complications. They were also given the same QOL survey that they filled out at the time of initial enrollment. These follow-up surveys were administered between 3-6 times throughout the year. Subjects' charts were routinely reviewed over the study, monitoring for ER visits, hospital admissions and line related complications.	Total n=23 Participants Total of all reporting groups
Age, Continuous	4.99 years STANDARD_DEVIATION 4.13 • n=12 Participants	5.46 years STANDARD_DEVIATION 5.16 • n=11 Participants	5.21 years STANDARD_DEVIATION 4.53 • n=23 Participants
Sex: Female, Male Female	6 Participants n=12 Participants	4 Participants n=11 Participants	10 Participants n=23 Participants
Sex: Female, Male Male	6 Participants n=12 Participants	7 Participants n=11 Participants	13 Participants n=23 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 participants n=12 Participants	11 participants n=11 Participants	23 participants n=23 Participants

PRIMARY outcome

Timeframe: For a maximum of 1 year from enrollment

Number of line breaks defined as any mechanical trauma to the line that required repair but not replacement of the line.

Outcome measures

Measure	Device n=11 Participants Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=10 Participants Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Primary Outcome - Line Breaks	.05 Line breaks/month Standard Deviation .09	.05 Line breaks/month Standard Deviation .07

PRIMARY outcome

Timeframe: For a maximum of 1 year from enrollment

Number of line replacements in which a line was removed from the patient and a new line was placed.

Outcome measures

Measure	Device n=11 Participants Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=10 Participants Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Primary Outcome - Line Replacement	.076 Events per month Standard Deviation .15	.05 Events per month Standard Deviation .16

PRIMARY outcome

Timeframe: For a maximum of 1 year from enrollment

Number of line infections defined as a positive blood culture drawn from a central line.

Outcome measures

Measure	Device n=11 Participants Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=10 Participants Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Primary Outcome - Line Infections	.086 Infections/Month Standard Deviation .12	.075 Infections/Month Standard Deviation .12

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=33 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=30 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
How Has the Vest or Dressing Affected Your Ability as a Family to Participate in Daily Activities?	3.82 score on a scale Standard Deviation .982	2.875 score on a scale Standard Deviation .712

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses for an individual was 5 over a 12 month period.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=22 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=36 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
How Has the Vest or Dressing Affected Your Child's Ability to be Active?	3.45 score on a scale Standard Deviation 1.06	3.78 score on a scale Standard Deviation 1.02

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=36 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=31 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
How Has the Vest or Dressing Affected Your Child's Ability to Participate in Typical Activities With Peers or Siblings?	3.86 score on a scale Standard Deviation 1.10	2.74 score on a scale Standard Deviation 0.73

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better and 6 being non applicable. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=32 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=31 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
How Has the Vest or Dressing Affected Your Ability to Keep Your Child's Central Line Safe?	4.03 score on a scale Standard Deviation 1.12	3.23 score on a scale Standard Deviation 0.80

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=43 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=32 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Have You Been Worried About the Safety of Your Child's Central Line?	2.42 score on a scale Standard Deviation 1.2	2.84 score on a scale Standard Deviation 1.02

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=39 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=29 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Has Your Child Been Able to Take a Long Walk or Play?	3.37 score on a scale Standard Deviation .82	3.41 score on a scale Standard Deviation .87

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=31 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=27 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Has Your Child Been Able to Take a Short Walk Outside of the House?	3.68 score on a scale Standard Deviation .79	3.52 score on a scale Standard Deviation .89

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=31 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=19 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Are You Worried About Your Child's Current Health?	2.61 score on a scale Standard Deviation 0.99	2.74 score on a scale Standard Deviation 1.15

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=42 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=25 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Has Your Child Needed to Stay in Bed or a Chair During the Day?	1.19 score on a scale Standard Deviation .51	1.4 score on a scale Standard Deviation .76

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=42 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=25 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Has Your Child Needed Help With Eating, Dressing, Washing or Using the Toilet?	1.19 score on a scale Standard Deviation .51	1.4 score on a scale Standard Deviation .76

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=40 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=26 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Is Your Child Able to Socialize?	3.33 score on a scale Standard Deviation .83	3.35 score on a scale Standard Deviation 1.02

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=34 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=20 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Is Your Child Able to do Sports/Exercise?	2.68 score on a scale Standard Deviation 1.01	2.85 score on a scale Standard Deviation 1.23

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=28 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=15 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Is Your Child Able to Attend School/Pre-school?	2.96 score on a scale Standard Deviation 1.26	2.73 score on a scale Standard Deviation 1.33

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=26 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=18 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Does Having a Central Line Affect His/Her Participation in School?	2.11 score on a scale Standard Deviation 1.18	2.33 score on a scale Standard Deviation 1.28

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=26 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=18 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Does Having a Central Line Affect His or Her Learning at School?	1.5 score on a scale Standard Deviation 0.81	1.67 score on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=34 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=25 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Is Your Child Able to Take Part in Hobbies or Leisure Activities?	2.82 score on a scale Standard Deviation .94	3.28 score on a scale Standard Deviation .89

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=40 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=22 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Is Your Child Able to Feel Independent?	3.13 score on a scale Standard Deviation 1.09	3.27 score on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=39 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=30 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Has the Vest or Dressing Been Easy to Use?	3.54 score on a scale Standard Deviation .72	3.2 score on a scale Standard Deviation .89

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=38 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=26 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Has the Vest or Dressing Been Comfortable to Wear?	3 score on a scale Standard Deviation 1.07	2.15 score on a scale Standard Deviation 1.16

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=38 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=29 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Has the Vest or Dressing Kept You Child's Central Line Safe?	3.26 score on a scale Standard Deviation .98	3.45 score on a scale Standard Deviation .74

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=38 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=30 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Has the Vest or Dressing Prevented Your Child From Tampering With or Touching the Central Line?	3.16 score on a scale Standard Deviation 1.15	2.7 score on a scale Standard Deviation 1.15

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=38 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=27 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Has the Vest or Dressing Enabled Your Child to be More Active?	2.84 score on a scale Standard Deviation 1.17	2.67 score on a scale Standard Deviation 1.24

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=39 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=24 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
Has the Presence of a Central Line Affected Their Body Image?	1.72 score on a scale Standard Deviation 1.09	2.71 score on a scale Standard Deviation 1.33

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-10 with 1 being very bad, 10 being very good. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=40 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=32 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
How Would You Rate Your Child's Quality of Life on a Scale of 1 to 10?	9.16 score on a scale Standard Deviation 1.04	8.28 score on a scale Standard Deviation 1.78

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from -5 to 5 with -5 being very bad, 5 being very well. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=43 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=32 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
How Would You Rate Your Child's Ability to Cope With Day to Day Activities?	4.23 score on a scale Standard Deviation 1.41	3.5 score on a scale Standard Deviation 1.87

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from -5 to 5 with -5 being very bad, 5 being very well. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=41 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=32 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
How Has Your Child's Quality-of-life Been Affected by Vest or Dressing?	3.17 score on a scale Standard Deviation 2.34	1.5 score on a scale Standard Deviation 2.38

SECONDARY outcome

Timeframe: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from -5 to 5 with -5 being very bad, 5 being very well. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.

Outcome measures

Measure	Device n=44 Total Responses Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Wearable Central Line Securement Device (Vest): The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.	Traditional Securement Dressing n=32 Total Responses Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Traditional Securement Dressing: This is a adhesive patch that is traditionally used to secure the external portion of a central line.
How Has Your Child's Quality-of-life Been Affected by Their Underlying Illness?	2.2 score on a scale Standard Deviation 2.86	.59 score on a scale Standard Deviation 2.72

Adverse Events

Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Securement Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ryan St. Pierre-Hetz

UPMC

Phone: 3154369898

Email: stpierrehetzre@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place