Glad Press 'n Seal® as a Temporary Moisture Barrier to Central Lines in Ambulatory Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01967836|
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : February 28, 2017
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer-related Problem/Condition Ambulatory Care||Device: Glad Press 'n Seal||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Glad Press 'n Seal® as a Temporary Moisture Barrier to Central Lines in Ambulatory Patients|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
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
- 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?
- 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
- 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 .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967836
|United States, Wisconsin|
|Rieman Cancer Center|
|Milwaukee, Wisconsin, United States, 53210|
|Wheaton Franciscan Healthcare-St Joseph campus|
|MIlwaukee, Wisconsin, United States, 53210|
|Milwaukee, Wisconsin, United States, 53215|
|Wheaton Franciscan - Wauwatosa Campus|
|Wauwatosa, Wisconsin, United States, 53226|
|Principal Investigator:||Maureen T Greene, PhD, RN||Wheaton Franciscan Healthcare|