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| ID | Type | Description | Link |
|---|---|---|---|
| ROR1701 | Other Identifier | Mayo Clinic |
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The aim of this study is to examine alterations in the skin microbiome that occur during radiation therapy. The study design will examine changes secondary to ionizing radiation, and correlate these changes with the development and severity of radiation dermatitis. The goal is to improve understanding of the mechanism of radiation dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lateral 3/4 of treatment field | placement of Mepitel on the lateral ¾ of the treatment field |
| |
| Medial 3/4 of treatment field | placement of Mepitel on the medial ¾ of the treatment field |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepitel | Other | Mepitel film will be placed on 3/4 of treatment field to protect from radiation dermatitis |
|
| Measure | Description | Time Frame |
|---|---|---|
| severity of radiation dermatitis in irradiated skin protected by Mepitel Film dressing versus uncovered skin receiving standard skin treatment | 12 weeks | |
| changes in the skin microbiome that occur secondary to ionizing radiation including quantitative analysis of S. aureus | 12 weeks | |
| changes in the skin microbiome of patients who use Mepitel including quantitative analysis of S. aureus | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Documented history of adhesive or tape allergy
Unable to provide written consent
Patients with prior radiotherapy to any portion of the planned treatment site
Brachytherapy patients
Patients with active rash, pre-existing dermatitis, lupus, or scleroderma
Gross dermal involvement at initiation of radiotherapy
Recent use of systemic or topical antibiotics or antifungal medications within 14 days of swab collection
Recent use of any of the following within 14 days of swab collection:
Clinical evidence of infection that in the judgement of the principle investigator would interfere with proper assessment of the skin microbiome
Prior organ or bone marrow transplant
Current lactation
Undergoing bilateral radiation
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post-mastectomy breast cancer patients
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Corbin, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C114834 | mepitel |
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| D017437 |
| Skin and Connective Tissue Diseases |