Trial Outcomes & Findings for Glad Press 'n Seal® as a Temporary Moisture Barrier to Central Lines in Ambulatory Patients (NCT NCT01967836)

NCT ID: NCT01967836

Last Updated: 2017-02-28

Results Overview

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?

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: complete one evaluation after each shower when using product
• Results posted on: 2017-02-28

Participant Flow

Participant milestones

Measure	Glad Press 'n Seal Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering as a means of bathing
Overall Study STARTED	20
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Glad Press 'n Seal n=20 Participants Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants
subjects with central IV catheter in place	20 participants n=5 Participants

PRIMARY outcome

Timeframe: complete one evaluation after each shower when using product

Population: 10 oncology and 1 ambulatory subjects returned 39 evaluation forms for primary analysis

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?

Outcome measures

Measure	Glad Press 'n Seal n=11 Participants Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering. Subject specific characteristics 19 subjects in oncology clinic sites were approached to participate; 9 refused participation 1 subject in ambulatory clinic was approached and was consented
Patient Subject Questionnaire Post Shower Evaluation Question 1	80 percentage of yes responses
Patient Subject Questionnaire Post Shower Evaluation Question 2	88 percentage of yes responses
Patient Subject Questionnaire Post Shower Evaluation Question 3	76 percentage of yes responses
Patient Subject Questionnaire Post Shower Evaluation Question 4	0 percentage of yes responses

PRIMARY outcome

Timeframe: Reported afer each subject showering survey completion

0 Not at all satisfied 10 Very satisfied

Outcome measures

Measure

Glad Press 'n Seal n=11 Participants Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering. Subject specific characteristics 19 subjects in oncology clinic sites were approached to participate; 9 refused participation 1 subject in ambulatory clinic was approached and was consented

Patient Satisfaction Mean on a 0-10 Likert Scale on the Use of Glad Press 'n Seal During Showering. 40 Subjects Reports.

7.65 units on a scale Standard Deviation 2.91

SECONDARY outcome

Timeframe: Inspection of central line site and dressing upon return to schduled clinic visit up to 30 days

Population: Nurse questionnaire evaluation forms were completed relative to subjects questionnaires being returned at 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

1. Line dressing intact (Yes) is in place (reporting on 20 lines on 28 RN observations)

2. Absence (No) of local skin irritation,

3. Dislodgement of the IV line/needle (No) with the IV site upon subject return to the clinic and verification by the subject .

Outcome measures

Measure	Glad Press 'n Seal n=28 Nurse Observation of IV Site Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering. Subject specific characteristics 19 subjects in oncology clinic sites were approached to participate; 9 refused participation 1 subject in ambulatory clinic was approached and was consented
Clinic Nurse Observation of Subjects, Who Used Intervention Device, at the Next Clinic Visit Nurse Question 2	93 percentage of observation
Clinic Nurse Observation of Subjects, Who Used Intervention Device, at the Next Clinic Visit Nurse Question 3	0 percentage of observation
Clinic Nurse Observation of Subjects, Who Used Intervention Device, at the Next Clinic Visit Nurse Question 1	91 percentage of observation

Adverse Events

Glad Press 'n Seal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Maureen Greene

Ascension Wisconsin

Phone: 414-447-2716

Email: maureen.greene@ascension.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place