Ambulatory Care, Cancer-related Problem/Condition
Conditions
Keywords
Invasive Line, IV Dressing protection, Hygiene, Oncology, Ambulatory Care
Brief summary
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.
Detailed description
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.
Interventions
DEVICEGlad Press 'n Seal
Application of Glad Press n' Seal product as an IV site dressing protection during subject showering
Sponsors
Maureen T Greene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects requiring mediport or peripherally inserted central venous catheter line access for 3-5 days * Able to read and write English * Use showering as a means of home hygiene
Exclusion criteria
* Subjects with eczema/psoriasis at the line insertion area * Subjects with active line/site irritation/infection * Subjects on chemotherapy protocols including anti-epidermal growth factor receptor drugs (cetuximab, panitumumab) or ipilimumab as there is a high incidence of skin rash as a side effect of these medications * Patients who do not intend to shower as a means of home hygiene
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Subject Questionnaire Post Shower Evaluation | complete one evaluation after each shower when using product | Percentage of responses to evaluation questions (Percentage reported are yes responses) for the following questions. 40 surveys were returned from 11 patient subjects. 1. Did you need assistance to place the Glad Press 'n Seal to your IV area? 2. Was the area covered by the Glad Press 'n Seal dry after taking it off? 3. Was the dressing covering your IV undamaged after taking off the Glad Press 'n Seal? 4. Did you feel the IV Line was accidentally pulled at all with the use of the Glad Press 'n Seal? 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? |
| Patient Satisfaction Mean on a 0-10 Likert Scale on the Use of Glad Press 'n Seal During Showering. 40 Subjects Reports. | Reported afer each subject showering survey completion | 0 Not at all satisfied 10 Very satisfied |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinic Nurse Observation of Subjects, Who Used Intervention Device, at the Next Clinic Visit | Inspection of central line site and dressing upon return to schduled clinic visit up to 30 days | The secondary outcomes of the study are clinic nurse observed problems. Percentage of yes responses of nurse observations of site at clinic visit 1. Line dressing intact (Yes) is in place (reporting on 20 lines on 28 RN observations) 2. Absence (No) of local skin irritation, 3. Dislodgement of the IV line/needle (No) with the IV site upon subject return to the clinic and verification by the subject . |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Glad Press 'n Seal |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
| subjects with central IV catheter in place | 20 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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
Time frame: Reported afer each subject showering survey completion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glad Press 'n Seal | Patient Satisfaction Mean on a 0-10 Likert Scale on the Use of Glad Press 'n Seal During Showering. 40 Subjects Reports. | 7.65 units on a scale | Standard Deviation 2.91 |
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. 1. Did you need assistance to place the Glad Press 'n Seal to your IV area? 2. Was the area covered by the Glad Press 'n Seal dry after taking it off? 3. Was the dressing covering your IV undamaged after taking off the Glad Press 'n Seal? 4. Did you feel the IV Line was accidentally pulled at all with the use of the Glad Press 'n Seal? 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?
Time frame: complete one evaluation after each shower when using product
Population: 10 oncology and 1 ambulatory subjects returned 39 evaluation forms for primary analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Glad Press 'n Seal | Patient Subject Questionnaire Post Shower Evaluation | Question 1 | 80 percentage of yes responses |
| Glad Press 'n Seal | Patient Subject Questionnaire Post Shower Evaluation | Question 2 | 88 percentage of yes responses |
| Glad Press 'n Seal | Patient Subject Questionnaire Post Shower Evaluation | Question 3 | 76 percentage of yes responses |
| Glad Press 'n Seal | Patient Subject Questionnaire Post Shower Evaluation | Question 4 | 0 percentage of yes responses |
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 1. Line dressing intact (Yes) is in place (reporting on 20 lines on 28 RN observations) 2. Absence (No) of local skin irritation, 3. Dislodgement of the IV line/needle (No) with the IV site upon subject return to the clinic and verification by the subject .
Time frame: Inspection of central line site and dressing upon return to schduled clinic visit up to 30 days
Population: Nurse questionnaire evaluation forms were completed relative to subjects questionnaires being returned at next clinic visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Glad Press 'n Seal | Clinic Nurse Observation of Subjects, Who Used Intervention Device, at the Next Clinic Visit | Nurse Question 1 | 91 percentage of observation |
| Glad Press 'n Seal | Clinic Nurse Observation of Subjects, Who Used Intervention Device, at the Next Clinic Visit | Nurse Question 2 | 93 percentage of observation |
| Glad Press 'n Seal | Clinic Nurse Observation of Subjects, Who Used Intervention Device, at the Next Clinic Visit | Nurse Question 3 | 0 percentage of observation |