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

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ClinicalTrials.gov Identifier: NCT01967836
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : February 28, 2017
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Maureen T Greene, Wheaton Franciscan Healthcare

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.

Condition or disease Intervention/treatment Phase
Cancer-related Problem/Condition Ambulatory Care Device: Glad Press 'n Seal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Glad Press 'n Seal® as a Temporary Moisture Barrier to Central Lines in Ambulatory Patients
Study Start Date : October 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Glad Press 'n Seal
Cohort Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line
Device: Glad Press 'n Seal
Application of Glad Press n' Seal product as an IV site dressing protection during subject showering




Primary Outcome Measures :
  1. Patient Subject Questionnaire Post Shower Evaluation [ Time Frame: 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?


  2. Patient Satisfaction Mean on a 0-10 Likert Scale on the Use of Glad Press 'n Seal During Showering. 40 Subjects Reports. [ Time Frame: Reported afer each subject showering survey completion ]
    0 Not at all satisfied 10 Very satisfied


Secondary Outcome Measures :
  1. Clinic Nurse Observation of Subjects, Who Used Intervention Device, at the Next Clinic Visit [ Time Frame: 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 .



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967836


Locations
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United States, Wisconsin
Rieman Cancer Center
Milwaukee, Wisconsin, United States, 53210
Wheaton Franciscan Healthcare-St Joseph campus
MIlwaukee, Wisconsin, United States, 53210
WFH-St. Francis
Milwaukee, Wisconsin, United States, 53215
Wheaton Franciscan - Wauwatosa Campus
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
Maureen T Greene
Investigators
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Principal Investigator: Maureen T Greene, PhD, RN Wheaton Franciscan Healthcare

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Responsible Party: Maureen T Greene, Maureen T. Greene, PhD, RN, Wheaton Franciscan Healthcare
ClinicalTrials.gov Identifier: NCT01967836     History of Changes
Other Study ID Numbers: 13-059
First Posted: October 23, 2013    Key Record Dates
Results First Posted: February 28, 2017
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Maureen T Greene, Wheaton Franciscan Healthcare:
Invasive Line
IV Dressing protection
Hygiene
Oncology
Ambulatory Care