NCT01967836

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 23, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 28, 2017

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

1.5 years

First QC Date

October 7, 2013

Results QC Date

October 10, 2016

Last Update Submit

February 24, 2017

Conditions

Cancer-related Problem/ConditionAmbulatory Care

Keywords

Invasive LineIV Dressing protectionHygieneOncologyAmbulatory Care

Outcome Measures

Primary Outcomes (2)

  • 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. 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?

    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 Outcomes (1)

  • 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

Study Arms (1)

Glad Press 'n Seal

OTHER

Cohort Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line

Device: Glad Press 'n Seal

Interventions

Glad Press 'n SealDEVICE

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

Glad Press 'n Seal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rieman Cancer Center

Milwaukee, Wisconsin, 53210, United States

Location

Wheaton Franciscan Healthcare-St Joseph campus

Milwaukee, Wisconsin, 53210, United States

Location

WFH-St. Francis

Milwaukee, Wisconsin, 53215, United States

Location

Wheaton Franciscan - Wauwatosa Campus

Wauwatosa, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

Title
Dr Maureen Greene
Organization
Ascension Wisconsin
maureen.greene@ascension.org
414-447-2716

Study Officials

  • Maureen T Greene, PhD, RN

    Wheaton Franciscan Healthcare

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Maureen T. Greene, PhD, RN

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 23, 2013

Study Start

October 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

February 28, 2017

Results First Posted

February 28, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(4)