Foam Tape Allergy a Sticky Situation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Foam Tape Allergy a Sticky Situation

Conditions
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Medical Adhesive Allergy, Dermatologic Conditions, Dermatologic Lesions

Intervention / Treatment
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* Other: 2x2 inch piece of 3M microfoam adhesive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Foam-tape/Control<br>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. | Other: 2x2 inch piece of 3M microfoam adhesive<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cutaneous Irritancy Scoring System (CISS) | Categorical variables analyzed by chi-square, continuous variables with t-tests | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatology, Contact Dermatitis