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Search / Trial NCT03519438

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

Launched by MAYO CLINIC · Apr 26, 2018

Trial Information

Current as of August 02, 2025

Completed

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Rochester, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Kimberly Corbin, MD

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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