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

NCT ID: NCT01967836

Last Updated: 2017-02-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer-related Problem/Condition Ambulatory Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glad Press 'n Seal

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

Group Type OTHER

Glad Press 'n Seal

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glad Press 'n Seal

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maureen T Greene

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maureen T Greene

Maureen T. Greene, PhD, RN

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maureen T Greene, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Wheaton Franciscan Healthcare

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rieman Cancer Center

Milwaukee, Wisconsin, United States

Site Status

Wheaton Franciscan Healthcare-St Joseph campus

Milwaukee, Wisconsin, United States

Site Status

WFH-St. Francis

Milwaukee, Wisconsin, United States

Site Status

Wheaton Franciscan - Wauwatosa Campus

Wauwatosa, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13-059

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PureWick™ Adolescent Study
NCT06631313 COMPLETED NA
Memory Gel and Shape Combined Cohort
NCT02919592 ACTIVE_NOT_RECRUITING NA