Evaluating Mepitel in Post-mastectomy Patients and the Role of the Skin Microbiome in Radiation Dermatitis

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Evaluating the Efficacy of Mepitel in Post-mastectomy Breast Cancer Patients, and Examining the Role of the Skin Microbiome in Radiation Dermatitis

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: Mepitel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years. Histological confirmation of breast or chest wall malignancy Primary or recurrent disease eligible Post-mastectomy with or without reconstruction Undergoing unilateral external beam radiotherapy at the Mayo Clinic - Rochester, MN or Mayo Clinic - Eau Claire, WI Ability to complete questionnaire(s) by themselves or with assistance Provide informed written consent Willing to consent for photography of radiation field Available to return to Mayo Clinic in within 6 weeks post-treatment for assessment Able to initiate thin film usage within first 3 days of the initiation of treatment 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: Systemic or topical steroids Use of systemic immunosuppressant drugs Use of ultraviolet light therapy 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lateral 3/4 of treatment field<br>placement of Mepitel on the lateral ¾ of the treatment field | Other: Mepitel<br>* Mepitel film will be placed on 3/4 of treatment field to protect from radiation dermatitis<br>|
| Medial 3/4 of treatment field<br>placement of Mepitel on the medial ¾ of the treatment field | Other: Mepitel<br>* Mepitel film will be placed on 3/4 of treatment field to protect from radiation dermatitis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 |