Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy

Description

This study will investigate the utility of Silk bioprotein, an FDA-approved and readily available post-surgical dressing, as a wound dressing for patients undergoing double-incision mastectomy for female-to-male gender affirmation surgery.

Conditions

Wound Healing

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Study Overview

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Study Details

Study overview

This study will investigate the utility of Silk bioprotein, an FDA-approved and readily available post-surgical dressing, as a wound dressing for patients undergoing double-incision mastectomy for female-to-male gender affirmation surgery.

The Utility of Silk Bioprotein as a Wound Dressing in Female-to-Male Double-Incision Mastectomy

Silk Bioprotein as a Wound Dressing for Double-Incision Mastectomy

Condition
Wound Healing
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Indiana University Health, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients over the age of 18 undergoing double-incision bilateral mastectomy for female-to-male gender affirming surgery with the principal investigator.
  • * Physicians will be plastic surgeons in the IU Health system
  • * Patients with a history of breast cancer.
  • * Patients with prior history of breast surgery.
  • * Patients with a prior history of radiation to the chest wall/breast.
  • * Patients with medical comorbidities that predispose to poor wound healing (diabetes, nutritional deficiency, smoking, inflammatory disease, chronic steroid use, immune deficiency, morbid obesity).
  • * Patients with a history of documented allergic reaction to Dermabond/Prineo or Silk Bioprotein dressing, or any of the constituents that make up these dressings.
  • * Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
  • * Physicians not in the IU Health system will not be included.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Indiana University,

Ivan Hadad, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

2026-06-14