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.

Study Overview

• Status: Completed
• Conditions: Ambulatory Care; Cancer-related Problem/Condition
• Intervention / Treatment: Device: Glad Press 'n Seal

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • MIlwaukee, Wisconsin, United States, 53210
      • Wheaton Franciscan Healthcare-St Joseph campus
    • Milwaukee, Wisconsin, United States, 53210
      • Rieman Cancer Center
    • Milwaukee, Wisconsin, United States, 53215
      • WFH-St. Francis
    • Wauwatosa, Wisconsin, United States, 53226
      • Wheaton Franciscan - Wauwatosa Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

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

Collaborators and Investigators

• Sponsor: Maureen T Greene
• Investigators: Principal Investigator: Maureen T Greene, PhD, RN, Wheaton Franciscan Healthcare

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: October 7, 2013
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimate): October 23, 2013

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 24, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Oncology; Ambulatory Care; Hygiene; Invasive Line; IV Dressing protection
• Other Study ID Numbers: 13-059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO