Foam Tape Allergy a Sticky Situation

NCT06059417 | Completed

• 1 other identifier: 2022-009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Medical Adhesive Allergy; Dermatologic Conditions; Dermatologic Lesions

Keywords

Dermatology; Contact Dermatitis

Outcome Measures

Primary Outcomes (1)

• Cutaneous Irritancy Scoring System

  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.

  48 hours

Study Arms (1)

Foam-tape/Control

OTHER

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

Interventions

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.

Foam-tape/Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hospitalized patients
• Adults unable to consent.
• Prisoners
• Adults with anaphylaxis to medical adhesives

Sponsors & Collaborators

• CHRISTUS Health: lead

Study Sites (2)

CHRISTUS Health/Texas A&M Health Science Center

Corpus Christi, Texas, 78404, United States

Location

CHRISTUS Health

Corpus Christi, Texas, 78404, United States

Location

Related Publications (5)

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

  PMID: 25581669 RESULT

• 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.

  PMID: 18346394 RESULT

• 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.

  PMID: 17385583 RESULT

• 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.

  PMID: 31676515 RESULT

• Vo NH, Richman P, Torres R, Xu KT, Miller M. The incidence of dermatitis following application of foam tape in healthy volunteers-A prospective trial. Am J Emerg Med. 2024 May;79:212-213. doi: 10.1016/j.ajem.2024.02.043. Epub 2024 Mar 5.

  PMID: 38462426 DERIVED

MeSH Terms

Conditions

Dermatitis, Contact

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: August 1, 2021
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

US (2)