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

Cancer-related Problem/Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967836
• Other study ID #: 13-059
• Status: Completed
• Phase: N/A
• First received: October 7, 2013
• Last updated: February 24, 2017
• Start date: October 2013
• Est. completion date: April 2015

Study information

• Verified date: February 2017
• Source: Wheaton Franciscan Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ambulatory Care
• Cancer-related Problem/Condition

Intervention

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

Locations

Country	Name	City	State
United States	Rieman Cancer Center	Milwaukee	Wisconsin
United States	WFH-St. Francis	Milwaukee	Wisconsin
United States	Wheaton Franciscan Healthcare-St Joseph campus	MIlwaukee	Wisconsin
United States	Wheaton Franciscan - Wauwatosa Campus	Wauwatosa	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Maureen T Greene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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