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OpenTrials
Completed

NCT Number: NCT03519438

Evaluating Mepitel in Post-mastectomy Patients and 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mepitel

Other

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 9, 2018
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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