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Foam Tape Allergy a Sticky Situation

Primary Purpose

Medical Adhesive Allergy, Dermatologic Conditions, Dermatologic Lesions

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2x2 inch piece of 3M microfoam adhesive
Sponsored by
CHRISTUS Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Medical Adhesive Allergy focused on measuring Dermatology, Contact Dermatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: Age 18 - 70 No reported history of dermatologic conditions No active dermatologic lesions Able to provide written consent to participation in the study. Resident and/or ancillary staff EXCLUSION CRITERIA: Hospitalized patients Adults unable to consent. Prisoners Adults with anaphylaxis to medical adhesives

Sites / Locations

  • CHRISTUS Health/Texas A&M Health Science Center
  • CHRISTUS Health

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Foam-tape/Control

Arm Description

One of the participants upper extremity (arm) was used for intervention and the same participants other arm was used as the control in this study. There was only 1 research arm in this study and all study participants were in it.

Outcomes

Primary Outcome Measures

Cutaneous Irritancy Scoring System (CISS)
Categorical variables analyzed by chi-square, continuous variables with t-tests

Secondary Outcome Measures

Full Information

First Posted
September 22, 2023
Last Updated
September 22, 2023
Sponsor
CHRISTUS Health
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1. Study Identification

Unique Protocol Identification Number
NCT06059417
Brief Title
Foam Tape Allergy a Sticky Situation
Official Title
Foam Tape Allergy a Sticky Situation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
September 13, 2022 (Actual)
Study Completion Date
September 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHRISTUS Health

4. Oversight

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

5. Study Description

Brief Summary
Foam tape is commonly used in the emergency department as a dressing over chest tubes owing to its occlusive and compressible properties. There is a paucity of data regarding the incidence of significant cutaneous reactions to this material. We conducted a prospective trial to evaluate the incidence of dermatitis following application of foam tape to the upper arm of a cohort of healthy volunteers.
Detailed Description
This was a prospective, interventional trial. We enrolled a cohort of consenting, healthy physicians, nurses, and ancillary staff at a teaching facility who did not have known hypersensitivity to foam tape. Study investigators applied a 2x2 inch piece of 3M microfoam adhesive to the medial aspect of each subject's upper arm. The contralateral arm served as a reference for comparison. The adhesive remained in place for 48 hours and the study authors assessed patients utilizing the previously validated Cutaneous Irritancy Scoring System (CISS). Categorical variables analyzed by chi-square, continuous variables with t-tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medical Adhesive Allergy, Dermatologic Conditions, Dermatologic Lesions
Keywords
Dermatology, Contact Dermatitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A cohort of consenting, healthy physicians, nurses, and ancillary staff at a teaching facility who did not have known hypersensitivity to foam tape were enrolled. Study investigators applied a 2x2 inch piece of 3M micro-foam adhesive to the medial aspect of each subject's upper arm. The contralateral arm served as a reference for comparison. The adhesive remained in place for 48 hours and the study authors assessed patients utilizing the previously validated Cutaneous Irritancy Scoring System (CISS).
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Foam-tape/Control
Arm Type
Other
Arm Description
One of the participants upper extremity (arm) was used for intervention and the same participants other arm was used as the control in this study. There was only 1 research arm in this study and all study participants were in it.
Intervention Type
Other
Intervention Name(s)
2x2 inch piece of 3M microfoam adhesive
Intervention Description
A 2x2 inch piece of 3M microfoam adhesive will be applied to the medial aspect of the subject's upper arm. The adhesive will remain in place for 48 hours at which time an investigator will remove the adhesive and assess the study area. A numerical value will be assigned based on the Cutaneous Irritancy Scoring System (CISS). The study site will be compared to the contra-lateral upper extremity at the end of the 48 hour period.
Primary Outcome Measure Information:
Title
Cutaneous Irritancy Scoring System (CISS)
Description
Categorical variables analyzed by chi-square, continuous variables with t-tests
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: Age 18 - 70 No reported history of dermatologic conditions No active dermatologic lesions Able to provide written consent to participation in the study. Resident and/or ancillary staff EXCLUSION CRITERIA: Hospitalized patients Adults unable to consent. Prisoners Adults with anaphylaxis to medical adhesives
Facility Information:
Facility Name
CHRISTUS Health/Texas A&M Health Science Center
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
CHRISTUS Health
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25581669
Citation
Smith SM, Zirwas MJ. Nonallergic reactions to medical tapes. Dermatitis. 2015 Jan-Feb;26(1):38-43. doi: 10.1097/DER.0000000000000098.
Results Reference
result
PubMed Identifier
18346394
Citation
Widman TJ, Oostman H, Storrs FJ. Allergic contact dermatitis from medical adhesive bandages in patients who report having a reaction to medical bandages. Dermatitis. 2008 Jan-Feb;19(1):32-7.
Results Reference
result
PubMed Identifier
17385583
Citation
Dykes PJ. The effect of adhesive dressing edges on cutaneous irritancy and skin barrier function. J Wound Care. 2007 Mar;16(3):97-100. doi: 10.12968/jowc.2007.16.3.27013.
Results Reference
result
PubMed Identifier
31676515
Citation
Wood MD, Powers J, Rechter JL. Comparative Evaluation of Chest Tube Insertion Site Dressings: A Randomized Controlled Trial. Am J Crit Care. 2019 Nov;28(6):415-423. doi: 10.4037/ajcc2019645.
Results Reference
result

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Foam Tape Allergy a Sticky Situation

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