Foam Tape Allergy a Sticky Situation

Dermatologic Conditions Clinical Trial

Official title:

Foam Tape Allergy a Sticky Situation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06059417
• Other study ID #: 2022-009
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: September 13, 2022

Study information

• Verified date: September 2023
• Source: CHRISTUS Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatologic Conditions
• Hypersensitivity
• Skin Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	CHRISTUS Health	Corpus Christi	Texas
United States	CHRISTUS Health/Texas A&M Health Science Center	Corpus Christi	Texas

Sponsors (1)

Lead Sponsor	Collaborator
CHRISTUS Health

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Smith SM, Zirwas MJ. Nonallergic reactions to medical tapes. Dermatitis. 2015 Jan-Feb;26(1):38-43. doi: 10.1097/DER.0000000000000098. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cutaneous Irritancy Scoring System (CISS)	Categorical variables analyzed by chi-square, continuous variables with t-tests	48 hours