Medical Adhesive AllergyNCT06059417
Foam Tape Allergy a Sticky Situation
A study testing 2x2 inch piece of 3M microfoam adhesive in people with Medical Adhesive Allergy and Dermatologic Conditions, run by CHRISTUS Health at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Medical Adhesive Allergy, Dermatologic Conditions, Dermatologic Lesions
- What is being tested?
- 2x2 inch piece of 3M microfoam adhesive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2021to 13 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hospitalized patients
- Adults unable to consent.
- Prisoners
- Adults with anaphylaxis to medical adhesives
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CHRISTUS Health/Texas A&M Health Science Center
Corpus Christi, Texas, 78404
CHRISTUS Health
Corpus Christi, Texas, 78404
About this study
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.
Read the detailed description
This was a prospective, interventional trial. The investigators 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 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). Categorical variables analyzed by chi-square, continuous variables with t-tests.
- Being tested
- 2x2 inch piece of 3M microfoam adhesive
- Keywords
- Dermatology, Contact Dermatitis
- Medical subject headings
- Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2x2 inch piece of 3M microfoam adhesiveOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 2x2 inch piece of 3M microfoam adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Aug 2021
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Medical Adhesive AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHRISTUS Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059417
- Sponsor's protocol ID
- 2022-009
- Status last verified
- Jul 2024
- First submitted
- 22 Sep 2023
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith SM, Zirwas MJ. Nonallergic reactions to medical tapes. Dermatitis. 2015 Jan-Feb;26(1):38-43. doi: 10.1097/DER.0000000000000098.
PubMed 25581669Widman 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.
PubMed 18346394Dykes 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.
PubMed 17385583Wood 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.
PubMed 31676515Vo 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.
PubMed 38462426
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foam Tape Allergy a Sticky Situation
- ClinicalTrials.gov ID
- NCT06059417
- Acronym / sponsor ID
- 2022-009
- Keywords
- Dermatology, Contact Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CHRISTUS HealthUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a prospective, interventional trial. The investigators 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 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). Categorical variables analyzed by chi-square, continuous variables with t-tests.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Foam-tape/Control | Other | Other: 2x2 inch piece of 3M microfoam adhesiveOne 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Hospitalized patients
- Adults unable to consent.
- Prisoners
- Adults with anaphylaxis to medical adhesives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2x2 inch piece of 3M microfoam adhesiveA 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. | Other | Foam-tape/Control |
Primary outcome
Cutaneous Irritancy Scoring System
Time frame: 48 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Results publication: PubMed 25581669Smith SM, Zirwas MJ. Nonallergic reactions to medical tapes. Dermatitis. 2015 Jan-Feb;26(1):38-43. doi: 10.1097/DER.0000000000000098.
- Results publication: PubMed 18346394Widman 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.
- Results publication: PubMed 17385583Dykes 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.
- Results publication: PubMed 31676515Wood 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.
- Derived from this study: PubMed 38462426Vo 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2x2 inch piece of 3M microfoam adhesive in people with Medical Adhesive Allergy and Dermatologic Conditions, run by CHRISTUS Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous Irritancy Scoring System (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06059417, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.