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

NCT ID: NCT03470012

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-16
• Study Completion Date: 2018-03-20

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.

Conditions

Skin (FLACC Scores of Test Subjects) After Tape Removal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Investigational tape

Group Type: EXPERIMENTAL

Multi-Purpose Gentle Tape

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

3M

INDUSTRY

Sponsor Role: collaborator

Solventum US LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary L Grove, PhD

Role: PRINCIPAL_INVESTIGATOR

Study Investigator

Locations

cyberDERM, inc.

Broomall, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

05-014050

Identifier Type: -

Identifier Source: org_study_id