Foam Tape Allergy a Sticky Situation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-09-13

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. The investigators 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.

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Detailed Description

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This was a prospective, interventional trial. The investigators 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 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). Categorical variables analyzed by chi-square, continuous variables with t-tests.

Conditions

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Medical Adhesive Allergy Dermatologic Conditions Dermatologic Lesions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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).

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Foam-tape/Control

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.

Group Type OTHER

2x2 inch piece of 3M microfoam adhesive

Intervention Type OTHER

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.

Interventions

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2x2 inch piece of 3M microfoam adhesive

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.

Intervention Type OTHER

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