Trial Outcomes & Findings for Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects (NCT NCT03470012)

Last Updated: 2024-10-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

24 Hours after initial tape application and after tape removal. Change in FLACC score between the time of tape removal and baseline.

Results posted on

2024-10-02

Participant Flow

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

Participant milestones

Participant milestones
Measure	Treatment Arm 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 Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=24 Participants 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.
Age, Categorical <=18 years	24 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	27.17 months STANDARD_DEVIATION 11.02 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Hours after initial tape application and after tape removal. Change in FLACC score between the time of tape removal and baseline.

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

Outcome measures

Outcome measures
Measure	Treatment Arm n=24 Participants 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.
The Face, Legs, Activity, Cry, Consolability (FLACC) Score.	0.29 units on a scale Interval 0.0 to 10.0

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Danielle Fendrick

cyberDERM

Phone: 610-325-0881

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place