NCT03633877

Durapore vs. Hy-Tape to Secure The Endotracheal Tube

A Prospective Randomized Trial of Durapore vs. Hy-Tape to Secure the Endotracheal Tube During Anesthesia.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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®.

Detailed 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®.

Conditions

• Erythema

Interventions

Type	Name	Description
DEVICE	DuraporeTM and Hy-Tape®	Medical tapes

Timeline

• Start date: 2018-09-17
• Primary completion: 2019-10-11
• Completion: 2019-10-11
• First posted: 2018-08-16
• Last updated: 2021-09-14

Locations

1 site across 1 country: United States