An interventional study of Tape Face Mask in Covid19, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-04.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
Methods 123 patients were enrolled in a randomized controlled trial at Eskenazi Hospital from April 2020 until October 2020. We permitted patients to either use their own mask (due to low resources institutionally) or we provided a surgical/cloth mask (early on relied on donated cloth masks for patients). Patients were randomized to a control (no tape over the mask/nose) or to the intervention (placing tape over the bridge of the nose of the face mask). Patients were evaluated at 30- and 60- minute intervals to assess for proper mask usage.
Study Design and Setting:
This study is a randomized control trial at Eskenazi Hospital ED from April 2020 until October 2020. Eskenazi Hospital is a busy, urban, academic hospital, level 1 trauma center, in downtown Indianapolis. Here we serve a racially diverse, underserved population, with over 100,000 annual ED visits. This work was approved by the Indiana University Institutional Review Board (protocol #2004425945).
Selection of Participants:
All patients presenting to the ED were screened for enrollment in this study by trained research personnel. All patients are required to wear facial coverings while in the ED, and after screening patients based on the exclusion criteria provided below, patients were offered enrollment in the study. Patients were randomly identified by their bed location in the ED via a random number generator. Patients were excluded from the study for: (1) pregnant; (2) prisoner; (3) not English or Spanish speaking (currently a large cohort of ethnic Latino/Latina/Hispanic are utilizing the ED and we can use interpreters to interpret for enrollment); (4) intoxicated or decompensated psychiatric illness; (5) presenting to the ED with a life-threatening condition; (6) allergic to standard tape and/or tegaderm. Patient consent was obtained if an individual agreed to participate in the study.
Interventions:
All patients included in this study were approached and offered enrollment in a study for addressing PPE. The control arm consisted of no active intervention, with the treatment arm placing standard surgical tape over the bridge of the nose to adhere the top of the mask to the bridge of the nose, thereby creating a physical barrier from removing the mask from the face. Patients were reevaluated at 30 minutes and 60 minutes after enrollment to assess for proper mask compliance.
Measurements: Assuming 50% current compliance, 58 patients per arm were needed to have an 80% power to detect a 25% difference assuming a two-sided chi-square test and alpha = 0.05.
Outcomes:
The primary outcome of this trial is proper mask utilization upon reevaluation at 30 and 60 minutes, with the mask at/under the chin, meanwhile completely covering the mouth and nose). Secondary outcomes of this trial were comparing the primary demographic and visit related covariates on initial screening, including age, sex, race/ethnicity, past medical history, social history, chief complaint, and disposition (admission vs. discharge).
Analysis:
Patient demographics and characteristics were compared between the control and treatment groups. To test for differences between groups, Microsoft excel statistical package was utilized, and the Chi-square test was used for categorical variables and the Wilcoxon test for continuous variables.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 123 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Indiana University is the lead sponsor of 982 studies on the registry; 199 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 117 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
placed a piece of tape to the bridge of the nose, adhering a face mask to the patient's face
Device: Tape Face Mask
Patients given a mask with no intervention to the mask
Adding tape to face mask
Proper Face Mask Use up to 60 Minutes
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).
Time frame: 60 minutes on Day 1
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.
| Milestone | Surgical Tape to Bridge of Nose | Standard of Care |
|---|---|---|
| Started | 60 | 63 |
| Completed | 60 | 63 |
| Not completed | 0 | 0 |
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).
| Participants | Surgical Tape to Bridge of Nose | Standard of Care |
|---|---|---|
| Proper Face Mask Use up to 60 Minutes | 58 | 52 |
Collected over within the single emergency department visit. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Surgical Tape to Bridge of Nose | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Standard of Care | 0/63 (0%) | 0/63 (0%) | 0/63 (0%) |
| Age, Categorical(Participants) | Surgical Tape to Bridge of Nose | Standard of Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 57 | 5 | 62 |
| >=65 years | 3 | 58 | 61 |
| Age, Continuous(years) | Surgical Tape to Bridge of Nose | Standard of Care | Total |
|---|---|---|---|
| Median | 41 (30.5 to 55.3) | 42 (31.5 to 55) | 41 (31 to 55) |
| Sex: Female, Male(Participants) | Surgical Tape to Bridge of Nose | Standard of Care | Total |
|---|---|---|---|
| Female | 25 | 36 | 61 |
| Male | 35 | 27 | 62 |
| Race (NIH/OMB)(Participants) | Surgical Tape to Bridge of Nose | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 32 | 35 | 67 |
| White | 26 | 24 | 50 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 3 | 3 |
| Region of Enrollment(participants) | Surgical Tape to Bridge of Nose | Standard of Care | Total |
|---|---|---|---|
| United States | 60 | 63 | 123 |
| mask type(Participants) | Surgical Tape to Bridge of Nose | Standard of Care | Total |
|---|---|---|---|
| Home mask | 35 | 46 | 81 |
| Provided mask | 25 | 17 | 42 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — data available upon request
Ran from Apr 2020 to primary completion in Oct 2020, 6 months.
Results were first posted in Oct 2022, 1 year 11 months after primary completion.
Of 1,295 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's 6 months is below that.
Counting every sponsor, half of 1,425 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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