Foam Tape Allergy a Sticky Situation

September 22, 2023 updated by: CHRISTUS Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Corpus Christi, Texas, United States, 78404
        • CHRISTUS Health
      • Corpus Christi, Texas, United States, 78404
        • CHRISTUS Health/Texas A&M Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cutaneous Irritancy Scoring System (CISS)
Time Frame: 48 hours
Categorical variables analyzed by chi-square, continuous variables with t-tests
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHRISTUS Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

September 13, 2022

Study Completion (Actual)

September 13, 2022

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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