Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06191627
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2023-12-20
Brief Title:
Patient Experience and Quality of Patch Testing on the Legs vs Back
Sponsor:
HealthPartners Institute
Organization:
HealthPartners Institute
Study Overview
Official Title:
Legs vs Back Patient Experience and Quality of Patch Testing for Allergic Contact Dermatitis on Different Body Sites
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The gold standard for the diagnosis of allergic contact dermatitis is patch testing during which allergens are affixed to the skin underneath tape and left for multiple days A large area of clear skin is thus required for successful testing
While the back is traditionally thought to be the ideal area for testing the thighs may be more available or advantageous This study seeks to randomize patients undergoing patch testing to have patches placed on the back or the thighs The investigators seek to understand the benefits of testing on the legs versus the back in terms of patient experience as well as achieving a successful test This study will measure patient experience using a survey administered to patients Quality of testing will be assessed by study coordinators prior the removal of patches
While the back is traditionally thought to be the ideal area for testing the thighs may be more available or advantageous This study seeks to randomize patients undergoing patch testing to have patches placed on the back or the thighs The investigators seek to understand the benefits of testing on the legs versus the back in terms of patient experience as well as achieving a successful test This study will measure patient experience using a survey administered to patients Quality of testing will be assessed by study coordinators prior the removal of patches
Detailed Description:
Background
Patch testing for ACD is a rigorous process While the patches are on the patients skin they must be careful not to perform movements that will cause the tape to detach thus compromising the integrity of the test The classical placement of patches is on the back due to a the large body surface area in which to place the patches b the generally flat surface which allows for adequate adhesion of the patches as opposed to a more rounded body surface and c the difficulty for patients to manipulate the area thus limiting patient interference with the testing site and ensuring the tape remains adhered The primary disadvantages of placing patches on ones back are the physical limitations eg the inability to raise ones arms above shoulder level bend twist or reach This has both comfort and practical disadvantages as patients find it hard to drive clothe and perform their activities of daily living ADLs These limitations improve the quality of the testing but it is reasonable to think that some discomfort could be prevented as an element of the physical limitations result from pulling or tugging due to the copious amounts of tape applied to achieve complete occlusion For patients who are parents or caregivers or those who are unable to take off of work during the week these limitations can prove to be an immense challenge Breastfeeding mothers may be unable to comfortably feed their infants Patients also report increased pain sleeping difficulties and worsening of rash during patch testing
Thus the investigators seek to investigate further patient comfort during patch testing to improve the patient experience The thighs have been used in our clinic as a patch testing as an alternative to the back either when the back has rash tattoos or too small an area for complete patch testing Anecdotal evidence suggests that the thighs may provide a more pleasant patch testing experience with decreased restrictions in mobility In our experience no limitation has been seen in terms of the quality of the patches with placement on the thighs To date there has been little published literature regarding the ideal location of patch testing either in respect to patient experience or quality of testing One study has proposed alternatives to the tape used to adhere patches in an effort to improve comfort Another study examined retrospective data to identify rates of symptoms during patch testing pain sleep difficulty need for medication site itching or itching elsewhere and worsening rash and their correlation with patch location Various significant statistical associations were found such as highest levels of pain with placement on the arms and increased need for medication and location on the chest However more information is needed comparing specifically the legs and the back the two most commonly tested areas in terms of patient comfort and quality of the test Additionally by obtaining a more holistic understanding of patient comfort the investigators will be able to derive a more useful and clinically applicable answer as to whether the legs or back is preferable for testing location
Sample Size
Sample size will be determined using a pragmatic approach based on time constraints and size of recruitment pool Because there exists no previously validated instrument to measure patient experience during patch testing or something similar the investigators will be developing our own survey The survey will document important demographic information and assess patient experience during patch testing using agreements questions that will be compared between both groups HealthPartners Center for Evaluation and Survey Research CESR will help to develop an effective instrument 30 patients will be enrolled per treatment group Between 10-20 patients are seen per week on average and the investigators estimate that 20 will not meet inclusion criteria Assuming that 50 of patients who meet enrollment criteria will agree to take part in the study data collection will take between 8-15 weeks 100 study follow through should be attainable as it is very rare for patients who begin patch testing to be lost to follow-up
Patch testing for ACD is a rigorous process While the patches are on the patients skin they must be careful not to perform movements that will cause the tape to detach thus compromising the integrity of the test The classical placement of patches is on the back due to a the large body surface area in which to place the patches b the generally flat surface which allows for adequate adhesion of the patches as opposed to a more rounded body surface and c the difficulty for patients to manipulate the area thus limiting patient interference with the testing site and ensuring the tape remains adhered The primary disadvantages of placing patches on ones back are the physical limitations eg the inability to raise ones arms above shoulder level bend twist or reach This has both comfort and practical disadvantages as patients find it hard to drive clothe and perform their activities of daily living ADLs These limitations improve the quality of the testing but it is reasonable to think that some discomfort could be prevented as an element of the physical limitations result from pulling or tugging due to the copious amounts of tape applied to achieve complete occlusion For patients who are parents or caregivers or those who are unable to take off of work during the week these limitations can prove to be an immense challenge Breastfeeding mothers may be unable to comfortably feed their infants Patients also report increased pain sleeping difficulties and worsening of rash during patch testing
Thus the investigators seek to investigate further patient comfort during patch testing to improve the patient experience The thighs have been used in our clinic as a patch testing as an alternative to the back either when the back has rash tattoos or too small an area for complete patch testing Anecdotal evidence suggests that the thighs may provide a more pleasant patch testing experience with decreased restrictions in mobility In our experience no limitation has been seen in terms of the quality of the patches with placement on the thighs To date there has been little published literature regarding the ideal location of patch testing either in respect to patient experience or quality of testing One study has proposed alternatives to the tape used to adhere patches in an effort to improve comfort Another study examined retrospective data to identify rates of symptoms during patch testing pain sleep difficulty need for medication site itching or itching elsewhere and worsening rash and their correlation with patch location Various significant statistical associations were found such as highest levels of pain with placement on the arms and increased need for medication and location on the chest However more information is needed comparing specifically the legs and the back the two most commonly tested areas in terms of patient comfort and quality of the test Additionally by obtaining a more holistic understanding of patient comfort the investigators will be able to derive a more useful and clinically applicable answer as to whether the legs or back is preferable for testing location
Sample Size
Sample size will be determined using a pragmatic approach based on time constraints and size of recruitment pool Because there exists no previously validated instrument to measure patient experience during patch testing or something similar the investigators will be developing our own survey The survey will document important demographic information and assess patient experience during patch testing using agreements questions that will be compared between both groups HealthPartners Center for Evaluation and Survey Research CESR will help to develop an effective instrument 30 patients will be enrolled per treatment group Between 10-20 patients are seen per week on average and the investigators estimate that 20 will not meet inclusion criteria Assuming that 50 of patients who meet enrollment criteria will agree to take part in the study data collection will take between 8-15 weeks 100 study follow through should be attainable as it is very rare for patients who begin patch testing to be lost to follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None