Erythema Clinical Trial
Official title:
A Prospective Randomized Trial of Durapore vs. Hy-Tape to Secure the Endotracheal Tube During Anesthesia.
Verified date | September 2021 |
Source | Tufts Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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®.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Tufts Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Tufts Medical Center |
United States,
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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