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Completed

NCT Number: NCT01967836

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

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.

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Key information

Conditions

Cancer-related Problem/Condition Ambulatory Care Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rieman Cancer Center, Milwaukee, Wisconsin, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glad Press 'n Seal

Device

Application of Glad Press n' Seal product as an IV site dressing protection during subject showering

Primary outcomes

  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.

    • 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?

  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 outcomes

  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

    • 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 .

Sponsors and collaborators

Lead sponsor

Maureen T Greene

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 23, 2013
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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