Adhesive Tape Placement on Patients' Masks in the Emergency Department Increases Compliance of Proper Face Mask Use
Phase: NA
Conditions: Covid19
Sponsor: Indiana University

Cover Page 
Title: Adhesive Tape Placement on Patients’ Masks in the ED Increases Compliance of 
Proper Face Mask Use 
Nicholas Pettit 
11/9/2021 
NCT04812184 
Protocol ID IUMASKstudy 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
Study Design and Setting:  
This study was an open-label randomized control trial at Eskenazi Hospital ED from April 2020 
to October 2020. Eskenazi Hospital is a busy, urban, academic, level 1 trauma center in 
downtown Indianapolis serving a racially diverse, underserved population with over 100,000 
annual ED visits. This study was approved by the Indiana University Institutional Review Board 
(protocol #2004425945) and registered on ClinicalTrials.gov (NCT04812184). 
 
Selection of Participants: 
Patients presenting to the ED were screened for enrollment by trained research personnel when 
one of the study authors was working. All patients in the ED were required to wear facial 
coverings by institutional policy, and patient-provided personal masks were acceptable. Patients 
were excluded if they were: (1) pregnant; (2) prisoners; (3) not English- or Spanish-speaking; (4) 
intoxicated or with decompensated psychiatric illness; (5) presenting to the ED with a life-
threatening condition; (6) allergic to standard tape and/or tegaderm. Patients were approached 
and verbal consent was obtained in their private ED room, then participants were randomized to 
either the control or intervention arms by simple randomization.  
 
Randomization: 

The randomization sequence was generated by a computerized random number generator 
(simple randomization). The randomization assignment was concealed from the study team and 
was provided within our REDCap database only after participants had been enrolled and 
provided informed consent. 
 
Interventions: 
 
Participants in the intervention arm had standard surgical tape placed over the bridge of the 
nose to adhere to the top of the mask (Supplemental Figure 1). Control participants had no 
intervention. Participants were told the study was about PPE use, but no additional instruction 
was given to participants regarding proper mask use, nor were reminders made by the research 
staff on proper mask use. No blinding was used in this study. 
 
Sample Size:  
Assuming 50% baseline proper mask use, 58 participants per arm were needed to have  80% 
power to detect a 25% relative difference in proper mask adherence assuming a two-sided chi-
square test and alpha = 0.05.  
 
Measurements:  
At time of consent, a researcher assessed participants for their mask type, age, gender, race, 
ethnicity, Charlson Comorbidity Index (CCI)8, and chief complaint, which were then entered into 
a REDCap database. After randomization, the participants were reevaluated at 60 minutes by 
the same researcher, and the mask location (correct placement, on chin, nose exposed, mask 
removed, nose/mouth exposed) and patient disposition (admission/discharge) were recorded 
(Supplemental Figure 1). Participants were reevaluated without notice and were blinded as to 
why the investigator was entering the room. 
 

Outcomes: 
The primary outcome of this trial was proper mask utilization at 60 minutes assessed by a 
researcher. A subgroup analysis was performed comparing the frequency of correct mask 
wearing by mask type (hospital-provided versus patient-supplied masks).  
 
Analysis: 
Patient demographics and characteristics were compared between the control and treatment 
groups (self-reported) to ensure balance after randomization. To test for differences between 
groups on outcomes, Microsoft Excel (Microsoft Corporation, Redmond, WA) was used, and the 
Chi-square test (or Fisher’s exact test for <5 counts) was used for categorical variables and the 
Wilcoxon test for continuous variables. All analyses were conducted by intention-to-treat.