Foam Tape Allergy a Sticky Situation

• ClinicalTrials.gov Identifier: NCT06059417
• Recruitment Status: Completed
• First Posted: September 28, 2023
• Last Update Posted: September 28, 2023
• Sponsor: CHRISTUS Health
• Information provided by (Responsible Party): CHRISTUS Health

Study Description

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. 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.

Condition or disease	Intervention/treatment	Phase
Medical Adhesive Allergy; Dermatologic Conditions; Dermatologic Lesions	Other: 2x2 inch piece of 3M microfoam adhesive	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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).
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Foam Tape Allergy a Sticky Situation
• Actual Study Start Date: August 1, 2021
• Actual Primary Completion Date: September 13, 2022
• Actual Study Completion Date: September 13, 2022

Arms and Interventions

Arm

Intervention/treatment

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.

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.

Outcome Measures

Primary Outcome Measures :

1. Cutaneous Irritancy Scoring System (CISS) [ Time Frame: 48 hours ]
   Categorical variables analyzed by chi-square, continuous variables with t-tests

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Texas

CHRISTUS Health/Texas A&M Health Science Center

Corpus Christi, Texas, United States, 78404

CHRISTUS Health

Corpus Christi, Texas, United States, 78404

Sponsors and Collaborators

CHRISTUS Health

More Information

Publications of Results:

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

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.

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.

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.

• Responsible Party: CHRISTUS Health
• ClinicalTrials.gov Identifier: NCT06059417
• Other Study ID Numbers: 2022-009
• First Posted: September 28, 2023
• Last Update Posted: September 28, 2023
• Last Verified: September 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHRISTUS Health:

Dermatology; Contact Dermatitis

Additional relevant MeSH terms:

Skin Diseases; Hypersensitivity; Immune System Diseases