Trial Outcomes & Findings for Adhesive Tape Placement on Patients' Masks in the Emergency Department Increases Compliance of Proper Face Mask Use (NCT NCT04812184)

Last Updated: 2022-10-04

Results Overview

The primary outcome of this trial is proper mask utilization upon reevaluation up to 60 minutes (with the mask at/under the chin, meanwhile completely covering the mouth and nose). At these time point a trained observer enters the room and observes the patient's face covering and its location on the face (correct, chin exposed, nose exposed, not on at all).

Recruitment status

COMPLETED

Study phase

Target enrollment

123 participants

Primary outcome timeframe

60 minutes on Day 1

Results posted on

2022-10-04

Participant Flow

Patients presenting to the ED were screened for enrollment by trained research personnel when one of the study authors was working. This study was an open-label randomized control trial at Eskenazi Hospital ED from April 2020 to October 2020.

Participant milestones

Participant milestones
Measure	Surgical Tape to Bridge of Nose placed a piece of tape to the bridge of the nose, adhering a face mask to the patient's face Tape Face Mask: Adding tape to face mask	Standard of Care Patients given a mask with no intervention to the mask
Overall Study STARTED	60	63
Overall Study COMPLETED	60	63
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adhesive Tape Placement on Patients' Masks in the Emergency Department Increases Compliance of Proper Face Mask Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgical Tape to Bridge of Nose n=60 Participants placed a piece of tape to the bridge of the nose, adhering a face mask to the patient's face Tape Face Mask: Adding tape to face mask	Standard of Care n=63 Participants Patients given a mask with no intervention to the mask, unless they had their own mask	Total n=123 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=5 Participants	5 Participants n=7 Participants	62 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	58 Participants n=7 Participants	61 Participants n=5 Participants
Age, Continuous	41 years n=5 Participants	42 years n=7 Participants	41 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	36 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	27 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	32 Participants n=5 Participants	35 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	63 participants n=7 Participants	123 participants n=5 Participants
mask type Home mask	35 Participants n=5 Participants	46 Participants n=7 Participants	81 Participants n=5 Participants
mask type Provided mask	25 Participants n=5 Participants	17 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes on Day 1

Population: Overall number of participants analyzed less than total 123. 2 patients were discharged prior to the 60 minute reevaluation from the standard of care group.

Outcome measures

Outcome measures
Measure	Surgical Tape to Bridge of Nose n=58 Participants placed a piece of tape to the bridge of the nose, adhering a face mask to the patient's face Tape Face Mask: Adding tape to face mask	Standard of Care n=61 Participants Patients given a mask with no intervention to the mask
Proper Face Mask Use up to 60 Minutes	58 Participants	52 Participants

Adverse Events

Surgical Tape to Bridge of Nose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

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

Nicholas Pettit

Indiana University School of Medicine

Phone: 18653688599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place