Foam Tape Allergy a Sticky Situation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Medical Adhesive Allergy Dermatitis Dermatitis, Contact Dermatologic Conditions Dermatologic Lesions Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRISTUS Health, Corpus Christi, Texas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2x2 inch piece of 3M microfoam adhesive

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.

Primary outcomes

Cutaneous Irritancy Scoring System

Time frame: 48 hours

A score will be assigned to the test area using the established Cutaneous Irritancy Scoring System. Using an established scoring system grading based on erythema and edema, a cumulative score will be obtained by adding erythema and edema. A score of 0 is no reaction. A score of 1-3 is mild, 4-5 is moderate, and 6-8 severe.

Sponsors and collaborators

Lead sponsor

CHRISTUS Health

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Sep 28, 2023
Registry last updated: Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed