Foam Tape Allergy a Sticky Situation

Sponsor

CHRISTUS Health (Other)

Overall Status

Completed

CT.gov ID

NCT06059417

Collaborator

(none)

Enrollment

Locations

Arm

13.4

Actual Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

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	N/A

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

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).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 :

Aug 1, 2021

Actual Primary Completion Date :

Sep 13, 2022

Actual Study Completion Date :

Sep 13, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

	Site	City	State	Country	Postal Code
1	CHRISTUS Health/Texas A&M Health Science Center	Corpus Christi	Texas	United States	78404
2	CHRISTUS Health	Corpus Christi	Texas	United States	78404

Sponsors and Collaborators

CHRISTUS Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CHRISTUS Health

ClinicalTrials.gov Identifier:

NCT06059417

Other Study ID Numbers:

2022-009

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by CHRISTUS Health

Dermatology

Contact Dermatitis

Additional relevant MeSH terms:

Skin Diseases

Hypersensitivity

Study Results

No Results Posted as of Sep 28, 2023