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

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

Study Overview

• Status: Completed
• Conditions: Skin (FLACC Scores of Test Subjects) After Tape Removal
• Intervention / Treatment: Device: Multi-Purpose Gentle 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • cyberDERM, inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 Hours after initial tape application and after tape removal. Change in FLACC score between the time of tape removal and baseline.

Collaborators and Investigators

• Sponsor: Solventum US LLC
• Collaborators: 3M
• Investigators: Principal Investigator: Gary L Grove, PhD, Study Investigator

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2018
• Primary Completion (Actual): January 23, 2018
• Study Completion (Actual): March 20, 2018

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 13, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 05-014050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes