Skin (FLACC Scores of Test Subjects) After Tape Removal
Conditions
Brief 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.
Interventions
DEVICEMulti-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.
Sponsors
3M
Solventum US LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 4 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects will be infants or children of either gender who meet the following criteria: 1. Who are healthy and who have intact skin at the test site with a baseline score of 0 for erythema 2. Who are between the ages of 6 months - 4 years of age (48 months) 3. Who have a Fitzpatrick Skin Type of I, II or III 4. Whose parent or legal representative agrees to not use any products (i.e. topical medications, creams, powders or ointments) on the test sites for 24 hours prior to the study start date 5. Whose parent or legal representative agrees to sponge bathe their child during the study but agrees to not bathe their child 1 hour before each visit. 6. Whose parent or legal representative agrees to not soak the tape during a sponge bath. If the site gets wet, parent or legal representative agrees to pat their child's back dry (no rubbing). 7. Whose parent or legal representative is willing to sign the Informed Consent Form (with photo release) and HIPAA Authorization.
Exclusion criteria
1. Who are known to be developmentally delayed 2. Who have any known allergy or sensitivity to tapes 3. Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test site 4. Who have had any exposure to other topical medications, creams, powders, or ointments on the test sites 24 hours prior to the start of the study 5. Who have had a strep infection within the 2 weeks prior to the start of the study 6. Who have a history of uncontrolled diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions 7. Has participated in any study in the last 2 weeks, or are currently participating in another study, or are scheduled to participate in another study during this study period. 8. Has any other skin disorders that, in the opinion of the investigator, will interfere with the study results or will increase undue risk for the child.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Face, Legs, Activity, Cry, Consolability (FLACC) Score. | 24 Hours after initial tape application and after tape removal. Change in FLACC score between the time of tape removal and baseline. | The Face, Legs, Activity, Cry, Consolability (FLACC) scale is a measurement used to assess pain for children Participants between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. Lower values represent lessening pain on the scale. At the 24 hour visit , a baseline FLACC score was recorded with the tape still in place. The tape was then removed and a FLACC score was recorded after removal. The reported value is the difference between FLACC after removal and FLACC at baseline. |
Countries
United States
Participant flow
Recruitment details
Subject recruitment occurred between 1/16/2018 and 1/23/2018.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Investigational tape
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. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Categorical <=18 years | 24 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 27.17 months STANDARD_DEVIATION 11.02 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
The Face, Legs, Activity, Cry, Consolability (FLACC) Score.
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is a measurement used to assess pain for children Participants between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. Lower values represent lessening pain on the scale. At the 24 hour visit , a baseline FLACC score was recorded with the tape still in place. The tape was then removed and a FLACC score was recorded after removal. The reported value is the difference between FLACC after removal and FLACC at baseline.
Time frame: 24 Hours after initial tape application and after tape removal. Change in FLACC score between the time of tape removal and baseline.
Population: Measure change in FLACC score for 24 Participants at the time of tape removal and baseline.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm | The Face, Legs, Activity, Cry, Consolability (FLACC) Score. | 0.29 units on a scale |