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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03519438
Collaborator
(none)
40
Enrollment
1
Location
19.5
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Other: Mepitel

Study Design

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 :
Apr 11, 2018
Actual Primary Completion Date :
Nov 25, 2019
Actual Study Completion Date :
Nov 25, 2019

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. severity of radiation dermatitis in irradiated skin protected by Mepitel Film dressing versus uncovered skin receiving standard skin treatment [12 weeks]

  2. changes in the skin microbiome that occur secondary to ionizing radiation including quantitative analysis of S. aureus [12 weeks]

  3. changes in the skin microbiome of patients who use Mepitel including quantitative analysis of S. aureus [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Kimberly Corbin, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Kimberly S. Corbin, Assistant Professor, Radiation Oncology, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03519438
Other Study ID Numbers:
  • 17-001546
  • ROR1701
First Posted:
May 9, 2018
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Additional relevant MeSH terms:
Breast Neoplasms
Dermatitis
Radiodermatitis

Study Results

No Results Posted as of May 20, 2022