Trial Outcomes & Findings for Adhesive Tape Trauma Evaluation of Two Gentle Tapes (NCT NCT01354106)
NCT ID: NCT01354106
Last Updated: 2024-10-02
Results Overview
Expert grader using Erythema/Edema Scale 0=No visible response 1. mild response 2. moderate response 3. severe response 4. extreme response
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
24 hours
Results posted on
2024-10-02
Participant Flow
recruitment started May 16, 2011 at cyberDERM
participant not to use any products on the test sites for 24 hours prior to the study state date.
Participant milestones
| Measure |
Adhesive Medical Tape
Each study participant received both treatment arms: 3M Kind Removal Silicone Tape (1" x 1.5" sample, applied one time, worn 24 hours) and 3M Micropore Silicone Tape (1" x 1.5" sample, applied one ime, worn 24 hours).
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Adhesive Medical Tape
Each study participant received both treatment arms: 3M Kind Removal Silicone Tape (1" x 1.5" sample, applied one time, worn 24 hours) and 3M Micropore Silicone Tape (1" x 1.5" sample, applied one ime, worn 24 hours).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Adhesive Tape Trauma Evaluation of Two Gentle Tapes
Baseline characteristics by cohort
| Measure |
Infant
n=26 Participants
Investigational adhesive tape control paper tape
|
|---|---|
|
Age, Categorical
<=18 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
2.88 years
STANDARD_DEVIATION 0.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursExpert grader using Erythema/Edema Scale 0=No visible response 1. mild response 2. moderate response 3. severe response 4. extreme response
Outcome measures
| Measure |
3M Kind Removal Silicone Tape
n=24 Participants
1" x 1.5" sample applied one time, worn for 24 hours.
|
3M Micropore Medical Tape
n=24 Participants
1" x 1.5" sample applied one time, worn for 24 hours.
|
|---|---|---|
|
Skin Trauma
|
0.93 Units on a scale
Standard Deviation 0.14
|
1.35 Units on a scale
Standard Deviation 0.11
|
Adverse Events
Investigational Adhesive Tape
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Paper Tape
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
Results disclosure agreements
- Principal investigator is a sponsor employee The proposed disclosure must be reviewed by the sponsor. The sponsor shall complete the review within 30 working days after receipt. The PI will discuss and consider in good faith the sponsor recommendations resulting from the review.
- Publication restrictions are in place
Restriction type: OTHER