Central Line-Associated Infection, Central Line Complication, Central Line Infection, Central Line Sepsis, Pediatric Disorder, Quality of Life, Short Gut Syndrome
Conditions
Brief summary
This study involves evaluating pediatric patients with central lines to determine differences in line complications and quality of life in those with a novel central line securement device (wrap) as compared to those who use a traditional securement device (dressing).
Detailed description
Children with central lines experience line breaks, line dislodgment's and line infections as a result of traditional securement techniques (dressings). These issues lead to the patients' increased health care utilization and possibly to restriction of movement and delayed development as the children are restricted in their home environment. The purpose of this study is to determine if a wearable central line securement device, can decrease the number of line breaks, line dislodgment and line infections as compared to traditional securement techniques. Events per month would be calculated for each arm before and after intervention and analyzed for treatment effect. The hypothesis is that the use of this wearable central line securement device can reduce line breaks, line dislodgment and line infections as compared to the traditional adhesive dressing. A secondary outcome for evaluation will be quality of life. This will be analyzed with a standardized quality of life survey and treatment effect will be reported as an ordinal odds ratio. Children are naturally active, however their activity is restricted by the parents given the delicate nature of their line. This study looks to see if quality of life can be improved a more secure wearable attachment device, as compared to traditional securement techniques.
Interventions
DEVICEWearable 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.
OTHERTraditional Securement Dressing
All subjects will use sterile dressings throughout the trial as this is the standard of care for central line securement. Subjects randomized to the dressing arm will continue to use standard of care sterile dressing as the only form of central line securement.
Sponsors
Ryan St. Pierre-Hetz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients with central lines ages 0-18 years old who have never worn a wearable central line securement device (vest) will be eligible for the study. Half of the participants will be randomized to the device arm while the other half of participants will be randomized to the non-device arm. They will be block randomized based on age upon enrollment. Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear. The study will follow participants prospectively for approximately one year (2020 - 2021).
Eligibility
Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a central line ages 0-18 years old who have never worn a wearable central line securement device (vest) will be eligible for the study.
Exclusion criteria
* Those children who currently wear a central line securement device (vest) * Children with central lines who are 19 years or older * Those females with central lines and Tanner 2 breast or greater breast development as a wearable central line securement device (vest) will not fit properly to secure the central line and may increase the risk of the central line complications. * If the patient does develop breast during the time of the study then the patient will no longer wear the wrap and will go back to securing their device in the traditional way. The investgators will still collect data on that patient and they will be evaluated in the device arm consistent with the intention to treat principle.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome - Line Breaks | 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. |
| Primary Outcome - Line Replacement | 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. |
| Primary Outcome - Line Infections | For a maximum of 1 year from enrollment | Number of line infections defined as a positive blood culture drawn from a central line. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| How Has the Vest or Dressing Affected Your Ability to Keep Your Child's Central Line Safe? | 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. |
| Have You Been Worried About the Safety of Your Child's Central Line? | 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. |
| Has Your Child Been Able to Take a Long Walk or Play? | 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. |
| Has Your Child Been Able to Take a Short Walk Outside of the House? | 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. |
| Are You Worried About Your Child's Current Health? | 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. |
| Has Your Child Needed to Stay in Bed or a Chair During the Day? | 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. |
| Has Your Child Needed Help With Eating, Dressing, Washing or Using the Toilet? | 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. |
| Is Your Child Able to Socialize? | 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. |
| Is Your Child Able to do Sports/Exercise? | 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. |
| Is Your Child Able to Attend School/Pre-school? | 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. |
| Does Having a Central Line Affect His/Her Participation in School? | 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. |
| Does Having a Central Line Affect His or Her Learning at School? | 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. |
| How Has the Vest or Dressing Affected Your Ability as a Family to Participate in Daily Activities? | 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. |
| Is Your Child Able to Feel Independent? | 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. |
| Has the Vest or Dressing Been Easy to Use? | 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. |
| Has the Vest or Dressing Been Comfortable to Wear? | 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. |
| Has the Vest or Dressing Kept You Child's Central Line Safe? | 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. |
| Has the Vest or Dressing Prevented Your Child From Tampering With or Touching the Central Line? | 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. |
| Has the Vest or Dressing Enabled Your Child to be More Active? | 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. |
| Has the Presence of a Central Line Affected Their Body Image? | 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. |
| How Would You Rate Your Child's Quality of Life on a Scale of 1 to 10? | 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. |
| How Would You Rate Your Child's Ability to Cope With Day to Day Activities? | 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. |
| How Has Your Child's Quality-of-life Been Affected by Vest or Dressing? | 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. |
| How Has Your Child's Quality-of-life Been Affected by Their Underlying Illness? | 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. |
| Is Your Child Able to Take Part in Hobbies or Leisure Activities? | 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. |
| How Has the Vest or Dressing Affected Your Child's Ability to be Active? | 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. |
| How Has the Vest or Dressing Affected Your Child's Ability to Participate in Typical Activities With Peers or Siblings? | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device 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. | 12 |
| Traditional Securement Dressing 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. | 11 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Patient did not want to wear the device | 1 | 0 |
Baseline characteristics
| Characteristic | Traditional Securement Dressing | Total | Device |
|---|---|---|---|
| Age, Continuous | 5.46 years STANDARD_DEVIATION 5.16 | 5.21 years STANDARD_DEVIATION 4.53 | 4.99 years STANDARD_DEVIATION 4.13 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 11 participants | 23 participants | 12 participants |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 6 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 11 |
| other Total, other adverse events | 0 / 12 | 0 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 |
Outcome results
Primary
Primary Outcome - Line Breaks
Number of line breaks defined as any mechanical trauma to the line that required repair but not replacement of the line.
Time frame: For a maximum of 1 year from enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Primary Outcome - Line Breaks | .05 Line breaks/month | Standard Deviation 0.09 |
| Traditional Securement Dressing | Primary Outcome - Line Breaks | .05 Line breaks/month | Standard Deviation 0.07 |
Comparison: A ratio of events per month was calculated for each participant. Participants were compared to themselves prior to intervention (i.e. event ratios pre intervention were compared to event ratios following intervention.)p-value: 0.029t-test, 1 sided
Primary
Primary Outcome - Line Infections
Number of line infections defined as a positive blood culture drawn from a central line.
Time frame: For a maximum of 1 year from enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Primary Outcome - Line Infections | .086 Infections/Month | Standard Deviation 0.12 |
| Traditional Securement Dressing | Primary Outcome - Line Infections | .075 Infections/Month | Standard Deviation 0.12 |
p-value: 0.334t-test, 1 sided
Primary
Primary Outcome - Line Replacement
Number of line replacements in which a line was removed from the patient and a new line was placed.
Time frame: For a maximum of 1 year from enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Primary Outcome - Line Replacement | .076 Events per month | Standard Deviation 0.15 |
| Traditional Securement Dressing | Primary Outcome - Line Replacement | .05 Events per month | Standard Deviation 0.16 |
Comparison: A ratio of events per month was calculated for each participant. Participants were compared to themselves prior to intervention (i.e. event ratios pre intervention were compared to event ratios following intervention.)p-value: 0.35t-test, 1 sided
Secondary
Are You Worried About Your Child's Current Health?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Are You Worried About Your Child's Current Health? | 2.61 score on a scale | Standard Deviation 0.99 |
| Traditional Securement Dressing | Are You Worried About Your Child's Current Health? | 2.74 score on a scale | Standard Deviation 1.15 |
p-value: 0.15695% CI: [0.067, 1.541]Chi-squared
Secondary
Does Having a Central Line Affect His/Her Participation in School?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Does Having a Central Line Affect His/Her Participation in School? | 2.11 score on a scale | Standard Deviation 1.18 |
| Traditional Securement Dressing | Does Having a Central Line Affect His/Her Participation in School? | 2.33 score on a scale | Standard Deviation 1.28 |
p-value: 0.41295% CI: [0.037, 3.842]Chi-squared
Secondary
Does Having a Central Line Affect His or Her Learning at School?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Does Having a Central Line Affect His or Her Learning at School? | 1.5 score on a scale | Standard Deviation 0.81 |
| Traditional Securement Dressing | Does Having a Central Line Affect His or Her Learning at School? | 1.67 score on a scale | Standard Deviation 1.03 |
p-value: 0.55895% CI: [0.094, 3.582]Chi-squared
Secondary
Has the Presence of a Central Line Affected Their Body Image?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Has the Presence of a Central Line Affected Their Body Image? | 1.72 score on a scale | Standard Deviation 1.09 |
| Traditional Securement Dressing | Has the Presence of a Central Line Affected Their Body Image? | 2.71 score on a scale | Standard Deviation 1.33 |
p-value: 0.01895% CI: [0.0424, 0.743]Chi-squared
Secondary
Has the Vest or Dressing Been Comfortable to Wear?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Has the Vest or Dressing Been Comfortable to Wear? | 3 score on a scale | Standard Deviation 1.07 |
| Traditional Securement Dressing | Has the Vest or Dressing Been Comfortable to Wear? | 2.15 score on a scale | Standard Deviation 1.16 |
p-value: 0.0995% CI: [0.766, 40.854]Chi-squared
Secondary
Has the Vest or Dressing Been Easy to Use?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Has the Vest or Dressing Been Easy to Use? | 3.54 score on a scale | Standard Deviation 0.72 |
| Traditional Securement Dressing | Has the Vest or Dressing Been Easy to Use? | 3.2 score on a scale | Standard Deviation 0.89 |
p-value: 0.46495% CI: [0.345, 10.278]Chi-squared
Secondary
Has the Vest or Dressing Enabled Your Child to be More Active?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Has the Vest or Dressing Enabled Your Child to be More Active? | 2.84 score on a scale | Standard Deviation 1.17 |
| Traditional Securement Dressing | Has the Vest or Dressing Enabled Your Child to be More Active? | 2.67 score on a scale | Standard Deviation 1.24 |
p-value: 0.48895% CI: [0.238, 20.348]Chi-squared
Secondary
Has the Vest or Dressing Kept You Child's Central Line Safe?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Has the Vest or Dressing Kept You Child's Central Line Safe? | 3.26 score on a scale | Standard Deviation 0.98 |
| Traditional Securement Dressing | Has the Vest or Dressing Kept You Child's Central Line Safe? | 3.45 score on a scale | Standard Deviation 0.74 |
p-value: 0.99195% CI: [0.107, 9.114]Chi-squared
Secondary
Has the Vest or Dressing Prevented Your Child From Tampering With or Touching the Central Line?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | 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 |
| Traditional Securement Dressing | Has the Vest or Dressing Prevented Your Child From Tampering With or Touching the Central Line? | 2.7 score on a scale | Standard Deviation 1.15 |
p-value: 0.22395% CI: [0.415, 43.326]Chi-squared
Secondary
Has Your Child Been Able to Take a Long Walk or Play?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Has Your Child Been Able to Take a Long Walk or Play? | 3.37 score on a scale | Standard Deviation 0.82 |
| Traditional Securement Dressing | Has Your Child Been Able to Take a Long Walk or Play? | 3.41 score on a scale | Standard Deviation 0.87 |
p-value: 0.31295% CI: [0.549, 6.562]Chi-squared
Secondary
Has Your Child Been Able to Take a Short Walk Outside of the House?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Has Your Child Been Able to Take a Short Walk Outside of the House? | 3.68 score on a scale | Standard Deviation 0.79 |
| Traditional Securement Dressing | Has Your Child Been Able to Take a Short Walk Outside of the House? | 3.52 score on a scale | Standard Deviation 0.89 |
p-value: 0.75395% CI: [0.112, 20.623]Chi-squared
Secondary
Has Your Child Needed Help With Eating, Dressing, Washing or Using the Toilet?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Has Your Child Needed Help With Eating, Dressing, Washing or Using the Toilet? | 1.19 score on a scale | Standard Deviation 0.51 |
| Traditional Securement Dressing | Has Your Child Needed Help With Eating, Dressing, Washing or Using the Toilet? | 1.4 score on a scale | Standard Deviation 0.76 |
p-value: 0.68495% CI: [0.009, 21.003]Chi-squared
Secondary
Has Your Child Needed to Stay in Bed or a Chair During the Day?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Has Your Child Needed to Stay in Bed or a Chair During the Day? | 1.19 score on a scale | Standard Deviation 0.51 |
| Traditional Securement Dressing | Has Your Child Needed to Stay in Bed or a Chair During the Day? | 1.4 score on a scale | Standard Deviation 0.76 |
p-value: 0.31895% CI: [0.099, 2.122]Chi-squared
Secondary
Have You Been Worried About the Safety of Your Child's Central Line?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Have You Been Worried About the Safety of Your Child's Central Line? | 2.42 score on a scale | Standard Deviation 1.2 |
| Traditional Securement Dressing | Have You Been Worried About the Safety of Your Child's Central Line? | 2.84 score on a scale | Standard Deviation 1.02 |
p-value: 0.09995% CI: [0.0706, 1.258]Chi-squared
Secondary
How Has the Vest or Dressing Affected Your Ability as a Family to Participate in Daily Activities?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | 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 0.982 |
| Traditional Securement Dressing | How Has the Vest or Dressing Affected Your Ability as a Family to Participate in Daily Activities? | 2.875 score on a scale | Standard Deviation 0.712 |
p-value: 0.00595% CI: [2.926154, 500.4402]Chi-squared
Secondary
How Has the Vest or Dressing Affected Your Ability to Keep Your Child's Central Line Safe?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | 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 |
| Traditional Securement Dressing | How Has the Vest or Dressing Affected Your Ability to Keep Your Child's Central Line Safe? | 3.23 score on a scale | Standard Deviation 0.8 |
p-value: 0.01195% CI: [1.71, 69.82]Chi-squared
Secondary
How Has the Vest or Dressing Affected Your Child's Ability to be Active?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | How Has the Vest or Dressing Affected Your Child's Ability to be Active? | 3.45 score on a scale | Standard Deviation 1.06 |
| Traditional Securement Dressing | How Has the Vest or Dressing Affected Your Child's Ability to be Active? | 3.78 score on a scale | Standard Deviation 1.02 |
p-value: 0.00395% CI: [3.22, 297.17]Chi-squared
Secondary
How Has the Vest or Dressing Affected Your Child's Ability to Participate in Typical Activities With Peers or Siblings?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | 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 1.1 |
| Traditional Securement Dressing | How Has the Vest or Dressing Affected Your Child's Ability to Participate in Typical Activities With Peers or Siblings? | 2.74 score on a scale | Standard Deviation 0.73 |
p-value: 0.00495% CI: [2.82, 265.45]Chi-squared
Secondary
How Has Your Child's Quality-of-life Been Affected by Their Underlying Illness?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | How Has Your Child's Quality-of-life Been Affected by Their Underlying Illness? | 2.2 score on a scale | Standard Deviation 2.86 |
| Traditional Securement Dressing | How Has Your Child's Quality-of-life Been Affected by Their Underlying Illness? | .59 score on a scale | Standard Deviation 2.72 |
p-value: 0.04995% CI: [1.004, 6.202]Chi-squared
Secondary
How Has Your Child's Quality-of-life Been Affected by Vest or Dressing?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | How Has Your Child's Quality-of-life Been Affected by Vest or Dressing? | 3.17 score on a scale | Standard Deviation 2.34 |
| Traditional Securement Dressing | How Has Your Child's Quality-of-life Been Affected by Vest or Dressing? | 1.5 score on a scale | Standard Deviation 2.38 |
p-value: 0.11395% CI: [0.737, 18.157]Chi-squared
Secondary
How Would You Rate Your Child's Ability to Cope With Day to Day Activities?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | 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 |
| Traditional Securement Dressing | How Would You Rate Your Child's Ability to Cope With Day to Day Activities? | 3.5 score on a scale | Standard Deviation 1.87 |
p-value: 0.10895% CI: [0.728, 24.84]Chi-squared
Secondary
How Would You Rate Your Child's Quality of Life on a Scale of 1 to 10?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | 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 |
| Traditional Securement Dressing | How Would You Rate Your Child's Quality of Life on a Scale of 1 to 10? | 8.28 score on a scale | Standard Deviation 1.78 |
p-value: 0.26995% CI: [0.364, 37.379]Chi-squared
Secondary
Is Your Child Able to Attend School/Pre-school?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Is Your Child Able to Attend School/Pre-school? | 2.96 score on a scale | Standard Deviation 1.26 |
| Traditional Securement Dressing | Is Your Child Able to Attend School/Pre-school? | 2.73 score on a scale | Standard Deviation 1.33 |
p-value: 0.71495% CI: [0.119, 22.514]Chi-squared
Secondary
Is Your Child Able to do Sports/Exercise?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Is Your Child Able to do Sports/Exercise? | 2.68 score on a scale | Standard Deviation 1.01 |
| Traditional Securement Dressing | Is Your Child Able to do Sports/Exercise? | 2.85 score on a scale | Standard Deviation 1.23 |
p-value: 0.43995% CI: [0.279, 18.927]Chi-squared
Secondary
Is Your Child Able to Feel Independent?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Is Your Child Able to Feel Independent? | 3.13 score on a scale | Standard Deviation 1.09 |
| Traditional Securement Dressing | Is Your Child Able to Feel Independent? | 3.27 score on a scale | Standard Deviation 1.03 |
p-value: 0.54495% CI: [0.189, 2.406]Chi-squared
Secondary
Is Your Child Able to Socialize?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Is Your Child Able to Socialize? | 3.33 score on a scale | Standard Deviation 0.83 |
| Traditional Securement Dressing | Is Your Child Able to Socialize? | 3.35 score on a scale | Standard Deviation 1.02 |
p-value: 0.4695% CI: [0.246, 22.194]Chi-squared
Secondary
Is Your Child Able to Take Part in Hobbies or Leisure Activities?
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Is Your Child Able to Take Part in Hobbies or Leisure Activities? | 2.82 score on a scale | Standard Deviation 0.94 |
| Traditional Securement Dressing | Is Your Child Able to Take Part in Hobbies or Leisure Activities? | 3.28 score on a scale | Standard Deviation 0.89 |
p-value: 0.67395% CI: [0.121, 3.9]Chi-squared