Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Durapore vs. Hy-Tape to Secure The Endotracheal Tube

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03633877
Recruitment Status : Completed
First Posted : August 16, 2018
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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®.

Condition or disease Intervention/treatment Phase
Erythema Device: DuraporeTM and Hy-Tape® Not Applicable

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®.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective Randomized Trial of Durapore vs. Hy-Tape to Secure the Endotracheal Tube During Anesthesia.
Actual Study Start Date : September 17, 2018
Actual Primary Completion Date : October 11, 2019
Actual Study Completion Date : October 11, 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: DuraporeTM on R, Hy-Tape ® on L
DuraporeTM and Hy-Tape® will be placed on patients' skin around the mouth during general anesthesia
 Device: DuraporeTM and Hy-Tape®
Medical tapes
Experimental: DuraporeTM on L, Hy-Tape ® on R
DuraporeTM and Hy-Tape® will be placed on patients' skin around the mouth during general anesthesia
 Device: DuraporeTM and Hy-Tape®
Medical tapes


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Skin erythema [ Time Frame: Standardized photos will be taken within 5 minutes of removing tape after surgery ]
    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).


Secondary Outcome Measures :
  1. Skin scaling, edema, and tearing [ Time Frame: Standardized photos will be taken within 5 minutes of removing tape after surgery ]
    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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633877


Locations
Layout table for location information
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02141
Sponsors and Collaborators
Tufts Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Andrea L Tsai, MD Tufts Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT03633877    
Other Study ID Numbers: IRB#: 13029
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Erythema
Skin Diseases
Skin Manifestations