Glad Press 'n Seal® as a Temporary Moisture Barrier to Central Lines in Ambulatory Patients
- Conditions
- Ambulatory CareCancer-related Problem/Condition
- Interventions
- Device: Glad Press 'n Seal
- Registration Number
- NCT01967836
- Lead Sponsor
- Maureen T Greene
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Glad Press 'n Seal Glad Press 'n Seal Cohort Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 .
Trial Locations
- Locations (4)
Rieman Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Wheaton Franciscan Healthcare-St Joseph campus
🇺🇸MIlwaukee, Wisconsin, United States
WFH-St. Francis
🇺🇸Milwaukee, Wisconsin, United States
Wheaton Franciscan - Wauwatosa Campus
🇺🇸Wauwatosa, Wisconsin, United States