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Durapore vs. Hy-Tape to Secure The Endotracheal Tube

Primary Purpose

Erythema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DuraporeTM and Hy-Tape®
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Erythema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DuraporeTM on R, Hy-Tape ® on L

DuraporeTM on L, Hy-Tape ® on R

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
August 14, 2018
Last Updated
September 7, 2021
Sponsor
Tufts Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03633877
Brief Title
Durapore vs. Hy-Tape to Secure The Endotracheal Tube
Official Title
A Prospective Randomized Trial of Durapore vs. Hy-Tape to Secure the Endotracheal Tube During Anesthesia.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
October 11, 2019 (Actual)
Study Completion Date
October 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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®.
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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DuraporeTM on R, Hy-Tape ® on L
Arm Type
Experimental
Arm Description
DuraporeTM and Hy-Tape® will be placed on patients' skin around the mouth during general anesthesia
Arm Title
DuraporeTM on L, Hy-Tape ® on R
Arm Type
Experimental
Arm Description
DuraporeTM and Hy-Tape® will be placed on patients' skin around the mouth during general anesthesia
Intervention Type
Device
Intervention Name(s)
DuraporeTM and Hy-Tape®
Intervention Description
Medical tapes
Primary Outcome Measure Information:
Title
Skin erythema
Description
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).
Time Frame
Standardized photos will be taken within 5 minutes of removing tape after surgery
Secondary Outcome Measure Information:
Title
Skin scaling, edema, and tearing
Description
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).
Time Frame
Standardized photos will be taken within 5 minutes of removing tape after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 Surgeries scheduled for anesthesia of duration more than 30 minutes after induction. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea L Tsai, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Durapore vs. Hy-Tape to Secure The Endotracheal Tube

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