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

NCT03470012 | Completed Results FDA Device

• 1 other identifier: 05-014050
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin (FLACC Scores of Test Subjects) After Tape Removal

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Investigational tape

Device: Multi-Purpose Gentle Tape

Interventions

Multi-Purpose Gentle Tape DEVICE

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.

Treatment Arm

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Who are healthy and who have intact skin at the test site with a baseline score of 0 for erythema
• Who are between the ages of 6 months - 4 years of age (48 months)
• Who have a Fitzpatrick Skin Type of I, II or III
• 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
• 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.
• 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).
• Whose parent or legal representative is willing to sign the Informed Consent Form (with photo release) and HIPAA Authorization.

You may not qualify if:

• Who are known to be developmentally delayed
• Who have any known allergy or sensitivity to tapes
• Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test site
• 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
• Who have had a strep infection within the 2 weeks prior to the start of the study
• Who have a history of uncontrolled diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions
• 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.
• 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.

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

cyberDERM, inc.

Broomall, Pennsylvania, 19008, United States

Location

Limitations and Caveats

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

Results Point of Contact

• Title: Danielle Fendrick
• Organization: cyberDERM

dfendrick@cyberderm-inc.com

610-325-0881

Study Officials

• Gary L Grove, PhD

  Study Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 19, 2018
• Study Start: January 16, 2018
• Primary Completion: January 23, 2018
• Study Completion: March 20, 2018
• Last Updated: October 2, 2024
• Results First Posted: July 20, 2020

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)