Clinical trial NCT06059417: Foam Tape Allergy a Sticky Situation
Official title: Foam Tape Allergy a Sticky Situation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Adhesive Allergy
Dermatologic Conditions
Dermatologic Lesions
Keywords: Dermatology
Contact Dermatitis
Lead sponsor: CHRISTUS Health
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Cutaneous Irritancy Scoring System
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Corpus Christi
country: United States
facility: CHRISTUS Health/Texas A&M Health Science Center
state: Texas
city: Corpus Christi
country: United States
facility: CHRISTUS Health
state: Texas
Study officials:
References:
citation: Smith SM, Zirwas MJ. Nonallergic reactions to medical tapes. Dermatitis. 2015 Jan-Feb;26(1):38-43. doi: 10.1097/DER.0000000000000098.
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.
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.
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.