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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®.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date October 11, 2019
Est. primary completion date October 11, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age = 18 2. Surgeries scheduled for anesthesia of duration more than 30 minutes after induction. Exclusion Criteria: 1. Any patient that does not consent 2. Patients < 18 years old 3. Surgery in the prone position 4. Surgery on the head, brain, neck, teeth, mouth, eyes, or face Any patient who has: 5. Pre-existing skin erythema or other skin trauma 6. Lips piercings

Study Design


Related Conditions & MeSH terms


Intervention

Device:
DuraporeTM and Hy-Tape®
Medical tapes

Locations

Country Name City State
United States Tufts Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Skin erythema Skin photographs will be independently evaluated by three blinded dermatologists to determine presence and severity of perioral erythema. Photographs will be cropped such that only the perioral region is visible for assessment. Erythema will be evaluated on a scale of 0-3 (0 indicating none, 1 indicating mild, 2 indicating moderate, and 3 indicating severe). Standardized photos will be taken within 5 minutes of removing tape after surgery
Secondary Skin scaling, edema, and tearing Skin photographs will be independently evaluated by three blinded dermatologists to determine presence and severity of perioral scaling, edema, and tearing. Photographs will be cropped such that only the perioral region is visible for assessment. These outcomes will be evaluated on a scale of 0-3 (0 indicating none, 1 indicating mild, 2 indicating moderate, and 3 indicating severe). Standardized photos will be taken within 5 minutes of removing tape after surgery
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