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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-11

Study Completion Date

2019-11-25

Brief Summary

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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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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lateral 3/4 of treatment field

placement of Mepitel on the lateral ¾ of the treatment field

Mepitel

Intervention Type OTHER

Mepitel film will be placed on 3/4 of treatment field to protect from radiation dermatitis

Medial 3/4 of treatment field

placement of Mepitel on the medial ¾ of the treatment field

Mepitel

Intervention Type OTHER

Mepitel film will be placed on 3/4 of treatment field to protect from radiation dermatitis

Interventions

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Mepitel

Mepitel film will be placed on 3/4 of treatment field to protect from radiation dermatitis

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No