Foam Tape Allergy a Sticky Situation

Not Applicable

Completed

• Conditions: Dermatologic Lesions; Dermatologic Conditions; Medical Adhesive Allergy
• Interventions: Other: 2x2 inch piece of 3M microfoam adhesive

• Registration Number: NCT06059417
• Lead Sponsor: CHRISTUS Health

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. 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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2022-09-13
• Study Completion: 2022-09-13
• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Foam-tape/Control	2x2 inch piece of 3M microfoam adhesive	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.

Primary Outcome Measures

Name	Time	Method
Cutaneous Irritancy Scoring System	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.

Trial Locations

Locations (2)

CHRISTUS Health; 🇺🇸 Corpus Christi, Texas, United States

CHRISTUS Health/Texas A&M Health Science Center; 🇺🇸 Corpus Christi, Texas, United States