Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03470012
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
3M

Brief Summary:
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. Assessments were compared to those taken in a previous study.

Condition or disease Intervention/treatment Phase
Skin (FLACC Scores of Test Subjects) After Tape Removal Device: Multi-Purpose Gentle Tape Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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 : January 16, 2018
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : March 20, 2018

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.




Primary Outcome Measures :
  1. The change in the subject discomfort (from baseline to the final assessment) using the FLACC (face, legs, activity, cry, consolability) scale. [ Time Frame: 24 Hours ]
    Change from baseline FLACC scores of test subjects 2 minutes after tape is removed



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470012


Locations
Layout table for location information
United States, Pennsylvania
cyberDERM, inc.
Broomall, Pennsylvania, United States, 19008
Sponsors and Collaborators
3M

Layout table for additonal information
Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT03470012     History of Changes
Other Study ID Numbers: 05-014050
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No