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The purpose of this study is to see if Glad Press 'n Seal works as a moisture barrier for central line that is left in place during ambulatory oncology clinical care.
Enrolled subjects will be instructed on the application of the Glad Press 'n Seal product to their IV dressing for use during a shower activity. Practice with application and removal of the product will be supervised by the PI or RA. Questions will be answered and a commercially purchased box of the investigational product will be given to the subject for home use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glad Press 'n Seal | Other | Cohort Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glad Press 'n Seal | Device | Application of Glad Press n' Seal product as an IV site dressing protection during subject showering |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Subject Questionnaire Post Shower Evaluation | Percentage of responses to evaluation questions (Percentage reported are "yes" responses) for the following questions. 40 surveys were returned from 11 patient subjects.
Likert Scale response to the following question On a scale of 0 (would not use) to 10 (would continue to use) how satisfied were you in using Glad Press n Seal? | complete one evaluation after each shower when using product |
| Patient Satisfaction Mean on a 0-10 Likert Scale on the Use of Glad Press 'n Seal During Showering. 40 Subjects Reports. | 0 Not at all satisfied 10 Very satisfied | Reported afer each subject showering survey completion |
| Measure | Description | Time Frame |
|---|---|---|
| Clinic Nurse Observation of Subjects, Who Used Intervention Device, at the Next Clinic Visit | The secondary outcomes of the study are clinic nurse observed problems. Percentage of "yes" responses of nurse observations of site at clinic visit
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maureen T Greene, PhD, RN | Wheaton Franciscan Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rieman Cancer Center | Milwaukee | Wisconsin | 53210 | United States | ||
| Wheaton Franciscan Healthcare-St Joseph campus |
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| ID | Title | Description |
|---|---|---|
| FG000 | Glad Press 'n Seal | Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering as a means of bathing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects who present to ambulatory oncology or outpatient clinic sites with the presence of a centrally placed IV catheter for infusion therapy who meet were approached for consent
19 Oncology subjects who met criteria were approached with 9 declines to participate 1 ambulatory care subject was approached and accepted participation
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| ID | Title | Description |
|---|---|---|
| BG000 | Glad Press 'n Seal | Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Subject Questionnaire Post Shower Evaluation | Percentage of responses to evaluation questions (Percentage reported are "yes" responses) for the following questions. 40 surveys were returned from 11 patient subjects.
Likert Scale response to the following question On a scale of 0 (would not use) to 10 (would continue to use) how satisfied were you in using Glad Press n Seal? | 10 oncology and 1 ambulatory subjects returned 39 evaluation forms for primary analysis | Posted | Number | percentage of yes responses | complete one evaluation after each shower when using product |
|
18 months
Only pre-specified to monitor for device related adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glad Press 'n Seal | Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering as a means of bathing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Maureen Greene | Ascension Wisconsin | 414-447-2716 | maureen.greene@ascension.org |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Inspection of central line site and dressing upon return to schduled clinic visit up to 30 days |
| Milwaukee |
| Wisconsin |
| 53210 |
| United States |
| WFH-St. Francis | Milwaukee | Wisconsin | 53215 | United States |
| Wheaton Franciscan - Wauwatosa Campus | Wauwatosa | Wisconsin | 53226 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| subjects with central IV catheter in place | Number | participants |
|
Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering. Subject specific characteristics 19 subjects in oncology clinic sites were approached to participate; 9 refused participation 1 subject in ambulatory clinic was approached and was consented |
|
|
| Primary | Patient Satisfaction Mean on a 0-10 Likert Scale on the Use of Glad Press 'n Seal During Showering. 40 Subjects Reports. | 0 Not at all satisfied 10 Very satisfied | Posted | Mean | Standard Deviation | units on a scale | Reported afer each subject showering survey completion |
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|
|
| Secondary | Clinic Nurse Observation of Subjects, Who Used Intervention Device, at the Next Clinic Visit | The secondary outcomes of the study are clinic nurse observed problems. Percentage of "yes" responses of nurse observations of site at clinic visit
| Nurse questionnaire evaluation forms were completed relative to subjects questionnaires being returned at next clinic visit | Posted | Number | percentage of observation | Inspection of central line site and dressing upon return to schduled clinic visit up to 30 days | Nurse Observation of IV Site | Nurse Observation of IV Site |
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| 0 |
| 11 |
| 0 |
| 11 |
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| Title | Measurements |
|---|---|
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