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Evaluation of Mepitel Film® in Preventing Epidermitis in Patients Receiving Radiation Therapy for Breast Cancer

NCT04149522 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-08

No results posted yet for this study

Summary

The purpose of this research is to evaluate the use of Mepitel Film® in preventing radiation epidermitis in patients receiving radiation treatment for breast cancer. Mepitel® Film is a thin, flexible, waterproof, and breathable film made of a soft silicone layer and polyurethane film. Mepitel ® film is not made with natural rubber latex (NRL). It is FDA approved for the management of superficial wounds, such as superficial burns. As a part of this research study, the Mepitel Film® will be placed prior to participant's first radiation treatment, and will be removed one week following the end of treatment. Throughout the study, information will be collected to analyze at the end of the research study to determine if the Mepitel Film® helps prevent skin breakdown. The subjects will be followed per standard of care and examined for skin redness, warmth or swelling as normally examined and cared for during standard radiation therapy. If radiation burns are noted, the subject will be treated normally and depending on the severity of the radiation burns, may be removed from the study treatment and treated through standard of care.

Conditions

  • Breast Cancer
  • Radiotherapy; Adverse Effect, Dermatitis or Eczema
  • Radiotherapy Side Effect
  • Radiation Burn
  • Radiation Dermatitis
  • Radiotherapy; Complications

Interventions

DEVICE

Mepitel Film®

As a part of this research study, Mepitel Film® will be placed prior to a participant's first radiation treatment, and will be removed one week following the end of treatment. The Film will be placed by the physician or his/her designee to cover approximately one-half of the breast divided in the cephalo-caudal plane. The film will remain in place until one week following the completion of radiotherapy. Any loss of film applied will be replaced as needed. Application of the Film is done by research personnel clinically trained in its application procedures.

Sponsors & Collaborators

  • Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

    lead OTHER

Principal Investigators

  • Mark Trombetta, MD · AHN Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2023-08-31
Completion
2023-11-06
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04149522 on ClinicalTrials.gov