Trials / Completed
CompletedNCT03470012
Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Solventum US LLC · Industry
- Sex
- All
- Age
- 6 Months – 4 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study is to determine the relative gentleness of a new medical tape.
Detailed description
The objective of this study is to determine the relative gentleness of a new medical tape. A three-prong multidimensional evaluation consisting of expert grader, subject discomfort assessment, and laboratory assessments was used. One pre-study visit took place up to 7 days prior to the start of the study. The study was conducted over two days with one tape sample applied and removed. Assessments were taken on the final day. This was to mimic a normal tape application in health care practice.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Multi-Purpose Gentle Tape | The Multi-Purpose Gentle Tape is a general purpose medical adhesive tape for medical applications used primarily to secure dressings, lightweight tubing, and devices to skin. |
Timeline
- Start date
- 2018-01-16
- Primary completion
- 2018-01-23
- Completion
- 2018-03-20
- First posted
- 2018-03-19
- Last updated
- 2024-10-02
- Results posted
- 2020-07-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03470012. Inclusion in this directory is not an endorsement.