Durapore vs. Hy-Tape to Secure The Endotracheal Tube

NCT03633877 | Completed DMC

• 1 other identifier: IRB#: 13029
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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®.

Conditions

Erythema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Skin scaling, edema, and tearing

  Standardized photos will be taken within 5 minutes of removing tape after surgery

Study Arms (2)

DuraporeTM on R, Hy-Tape ® on L

EXPERIMENTAL

DuraporeTM and Hy-Tape® will be placed on patients' skin around the mouth during general anesthesia

Device: DuraporeTM and Hy-Tape®

DuraporeTM on L, Hy-Tape ® on R

EXPERIMENTAL

DuraporeTM and Hy-Tape® will be placed on patients' skin around the mouth during general anesthesia

Device: DuraporeTM and Hy-Tape®

Interventions

DuraporeTM and Hy-Tape® DEVICE

Medical tapes

DuraporeTM on L, Hy-Tape ® on R; DuraporeTM on R, Hy-Tape ® on L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Surgeries scheduled for anesthesia of duration more than 30 minutes after induction.

You may not qualify if:

• Any patient that does not consent
• Patients \< 18 years old
• Surgery in the prone position
• Surgery on the head, brain, neck, teeth, mouth, eyes, or face
• Any patient who has:
• Pre-existing skin erythema or other skin trauma
• Lips piercings

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02141, United States

Location

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea L Tsai, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Every patient will have each tape on each side of the mouth, with Hy-Tape® on one side and DuraporeTM on the other side according to the randomization schema.

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 16, 2018
• Study Start: September 17, 2018
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)