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



Status:Recruiting
Conditions:Breast Cancer, Cancer, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Oncology
Healthy:No
Age Range:18 - Any
Updated:10/17/2018
Start Date:April 11, 2018
End Date:May 2021
Contact:Clinical Trials Referral Office
Email:schneider.jessica@mayo.edu

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

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.


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
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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