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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03519438
Recruitment Status : Active, not recruiting
First Posted : May 9, 2018
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Kimberly S. Corbin, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment
Breast Cancer Other: Mepitel

Study Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Efficacy of Mepitel in Post-mastectomy Breast Cancer Patients, and Examining the Role of the Skin Microbiome in Radiation Dermatitis
Actual Study Start Date : April 11, 2018
Actual Primary Completion Date : May 17, 2019
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Lateral 3/4 of treatment field
placement of Mepitel on the lateral ¾ of the treatment field
 Other: Mepitel
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
 Other: Mepitel
Mepitel film will be placed on 3/4 of treatment field to protect from radiation dermatitis


Outcome Measures
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Primary Outcome Measures :
  1. severity of radiation dermatitis in irradiated skin protected by Mepitel Film dressing versus uncovered skin receiving standard skin treatment [ Time Frame: 12 weeks ]
  2. changes in the skin microbiome that occur secondary to ionizing radiation including quantitative analysis of S. aureus [ Time Frame: 12 weeks ]
  3. changes in the skin microbiome of patients who use Mepitel including quantitative analysis of S. aureus [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
post-mastectomy breast cancer patients
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519438


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Kimberly S. Corbin, Assistant Professor, Radiation Oncology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03519438    
Other Study ID Numbers: 17-001546
ROR1701 ( Other Identifier: Mayo Clinic )
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Additional relevant MeSH terms:
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Breast Neoplasms
Dermatitis
Radiodermatitis
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Radiation Injuries
Wounds and Injuries