Glad Press 'n Seal® as a Temporary Moisture Barrier to Central Lines in Ambulatory Patients

Study Overview
=================
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.

Official Title
-----------------
Glad Press 'n Seal® as a Temporary Moisture Barrier to Central Lines in Ambulatory Patients

Conditions
-----------------
Cancer-related Problem/Condition, Ambulatory Care

Intervention / Treatment
-----------------
* Device: Glad Press 'n Seal


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Glad Press 'n Seal<br>Cohort Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line | Device: Glad Press 'n Seal<br>* Application of Glad Press n' Seal product as an IV site dressing protection during subject showering<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. Did you need assistance to place the Glad Press 'n Seal to your IV area? Was the area covered by the Glad Press 'n Seal dry after taking it off? Was the dressing covering your IV undamaged after taking off the Glad Press 'n Seal? 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? | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 Line dressing intact (Yes) is in place (reporting on 20 lines on 28 RN observations) Absence (No) of local skin irritation, Dislodgement of the IV line/needle (No) with the IV site upon subject return to the clinic and verification by the subject . | Inspection of central line site and dressing upon return to schduled clinic visit up to 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Invasive Line, IV Dressing protection, Hygiene, Oncology, Ambulatory Care