Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects

• Sponsor: 3M (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03470012
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 11.6

Study Details

Study Description

Brief Summary

The objective of this study is to determine the relative gentleness of a new medical tape.

Condition or Disease	Intervention/Treatment	Phase
Skin (FLACC Scores of Test Subjects) After Tape Removal	Device: Multi-Purpose Gentle Tape	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects
• Actual Study Start Date: Jan 16, 2018
• Actual Primary Completion Date: Jan 23, 2018
• Actual Study Completion Date: Mar 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm Investigational tape	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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 4 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	cyberDERM, inc.	Broomall	Pennsylvania	United States	19008

Sponsors and Collaborators

• 3M

Investigators

• Principal Investigator: Gary L Grove, PhD, Study Investigator

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 11, 2017

More Information

Publications

None provided.

• Responsible Party: 3M
• ClinicalTrials.gov Identifier: NCT03470012
• Other Study ID Numbers: 05-014050
• First Posted: Mar 19, 2018
• Last Update Posted: Jul 20, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

Participant Flow

Recruitment Details	Subject recruitment occurred between 1/16/2018 and 1/23/2018.

Arm/Group Title	Treatment Arm
Arm/Group Description	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.
Period Title: Overall Study
STARTED	24
COMPLETED	24
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment Arm
Arm/Group Description	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.
Overall Participants	24
Age (Count of Participants)
<=18 years	24 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	27.17 (11.02)
Sex: Female, Male (Count of Participants)
Female	9 37.5%
Male	15 62.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	24 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	24 100%

Outcome Measures

1. Primary Outcome

Title	The Face, Legs, Activity, Cry, Consolability (FLACC) Score.
Description	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.

Outcome Measure Data

Analysis Population Description

Measure change in FLACC score for 24 Participants at the time of tape removal and baseline.

Arm/Group Title	Treatment Arm
Arm/Group Description	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.
Measure Participants	24
Mean (Full Range) [units on a scale]	0.29

Adverse Events

Time Frame	3 weeks
Arm/Group Title	Treatment Arm
Arm/Group Description	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.
All Cause Mortality
	Treatment Arm
	Affected / at Risk (%)	# Events
Total	0/24 (0%)
Serious Adverse Events
	Treatment Arm
	Affected / at Risk (%)	# Events
Total	0/24 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Arm
	Affected / at Risk (%)	# Events
Total	0/24 (0%)

Limitations/Caveats

Relatively small sample size and no comparator product. Hard to evaluate responses of infants.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.