Cancer-related Problem/ConditionNCT01967836
Glad Press 'n Seal® as a Temporary Moisture Barrier to Central Lines in Ambulatory Patients
A study testing Glad Press 'n Seal in people with Cancer-related Problem/Condition and Ambulatory Care, run by Maureen T Greene at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-related Problem/Condition, Ambulatory Care
- What is being tested?
- Glad Press 'n Seal
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rieman Cancer Center
Milwaukee, Wisconsin, 53210
Wheaton Franciscan Healthcare-St Joseph campus
Milwaukee, Wisconsin, 53210
WFH-St. Francis
Milwaukee, Wisconsin, 53215
Wheaton Franciscan - Wauwatosa Campus
Wauwatosa, Wisconsin, 53226
About this study
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.
Read the 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.
- Conditions
- Cancer-related Problem/Condition, Ambulatory Care
- Being tested
- Glad Press 'n Seal
- Keywords
- Invasive Line, IV Dressing protection, Hygiene, Oncology, Ambulatory Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glad Press 'n SealDevice
Application of Glad Press n' Seal product as an IV site dressing protection during subject showering
| Study group | Role | What they receive |
|---|---|---|
| Glad Press 'n Seal | Other | Cohort Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line Receives: Device: Glad Press 'n Seal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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
Measured: Reported afer each subject showering survey completion
Secondary outcomes (1)
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 .
Measured: Inspection of central line site and dressing upon return to schduled clinic visit up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer-related Problem/ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maureen T Greene
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maureen T Greene, Wheaton Franciscan Healthcare
- Investigators
- Maureen T Greene, PhD, RN, Principal investigator, Wheaton Franciscan Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967836
- Sponsor's protocol ID
- 13-059
- Status last verified
- Feb 2017
- First submitted
- 7 Oct 2013
- Last updated
- 28 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glad Press 'n Seal® as a Temporary Moisture Barrier to Central Lines in Ambulatory Patients
- ClinicalTrials.gov ID
- NCT01967836
- Acronym / sponsor ID
- 13-059
- Conditions
- Cancer-related Problem/Condition, Ambulatory Care
- Keywords
- Invasive Line, IV Dressing protection, Hygiene, Oncology, Ambulatory Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Maureen T GreeneUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Oct 2013 (estimated)
- Results
- Posted 28 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glad Press 'n Seal | Other | Device: Glad Press 'n SealCohort Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glad Press 'n SealApplication of Glad Press n' Seal product as an IV site dressing protection during subject showering | Device | Glad Press 'n Seal |
Primary outcome
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. 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?
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cancer-related Problem/Condition
Active, not recruiting
The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
Chronic Insomnia, Cancer-related Problem/Condition
RecruitingObservational study
Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care
Cardiovascular Complication, Cardiovascular Insufficiency
Not yet recruitingPhase 4
Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers and Mental Health.
Hepatitis B, Human Papilloma Virus
RecruitingPhase 1/2
Modafinil to Improve Fatiguability
Cancer-related Cognitive Difficulties, Cancer-related Problem/Condition
Active, not recruiting
Virtual Exercise Program to Reduce Cancer Related Fatigue
Cancer, Cancer-related Problem/Condition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maureen T Greene, PhD, RN principal investigator
Wheaton Franciscan Healthcare
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glad Press 'n Seal in people with Cancer-related Problem/Condition and Ambulatory Care, run by Maureen T Greene at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Subject Questionnaire Post Shower Evaluation (time frame: complete one evaluation after each shower when using product). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.