Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03633877 |
Other study ID # |
IRB#: 13029 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 17, 2018 |
Est. completion date |
October 11, 2019 |
Study information
Verified date |
September 2021 |
Source |
Tufts Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
While adhesive tape is commonly used to secure endotracheal tubes (ETT) during general
anesthesia, its use is also associated with facial skin injuries. Although a variety of
adhesive tapes are used in clinical practice, few studies have investigated the likelihood of
adhesives in producing injury. The purpose of this randomized, controlled, non-inferiority
study was to compare the proportion of facial skin injury with Durapore™ vs. Hy-Tape®.
Description:
Adhesive tapes are often used on the patient's face during general anesthesia. They are used
to fix the tracheal tube, nasopharyngeal temperature probe, nasogastric tube, and nerve
stimulator electrodes. An adhesive tape used in anesthesia needs to provide fast, secure
adhesion to prevent dislodgement of critical devices. The tape should be secure over time,
with changes over temperature, humidity, or exposure to fluids as occurring in the operating
room. However, the tape should be gentle enough that removal should not cause skin trauma to
the face. While the skin irritation is generally limited to mild erythema that resolves on
its own within a day or two of receiving anesthesia, the irritation may affect patient
satisfaction. Furthermore, serious injury, including full-thickness epidermal loss with
purpura has occurred at Tufts Medical Center with the use of 3MTM Durapore tape, requiring
several doctor visits in follow up.
Medical adhesive related skin injuries are estimated to impact at least 1.5 million patients
annually in the US with significant costs per incident. (1) At Tufts Medical Center, a
variety of adhesive tapes are used to secure the endotracheal tube during anesthesia,
including 3MTM Durapore (acrylate- based tape) and the Hy-Tape® Pink tape (zink-based tape)
with no preference for one or the other.
Hy-Tape's zinc oxide-based adhesive is claimed to be soothing to delicate skin, and removes
with minimum trauma, thereby reducing the chance of skin tears and tape burns. It also has
the unique quality of providing maximum adhesion when it reaches body temperature, without
getting more aggressive or breaking down over time as acrylic-based adhesive tapes do.
However, there is no scientific evidence to support this claim.
The purpose of this study is to compare the proportion of skin erythema after general
anesthesia with the use of DuraporeTM vs. Hy-Tape®.